ARTERIAL LINE KIT/1 20GA X 3"

Description of Event or Problem

A RADIAL ARTERIAL LINE WAS INSERTED IN ICU ON THE (B)(6) AND PT TRANSFERRED TO ICU POST OP. ARTERIAL LINE FUNCTIONING PROPERLY ¿ GOOD TRACE AND BLOOD ASPIRATION. SEPARATION OF ARTERIAL CATHETER FROM HUB REQUIRING SURGICAL REMOVAL. AT APPROXIMATELY 0200HRS ON (B)(6) 23 THE ARTERIAL WAVEFORM SUDDENLY DISAPPEARED. ON EXAMINATION OF THE ARTERIAL LINE HUB WAS STILL SUTURED IN AND DRESSING INTACT AND SITE WAS BLEEDING. WHEN DRESSING REMOVED IT WAS FOUND THAT THE ARTERIAL LINE HAS BROKEN. THE DISTAL PART OF THE LINE UNABLE TO BE FOUND. AN XRAY OF THE PATIENTS FOREARM WAS ATTENDED AND THE ARTERIAL LINE HAD DISLODGED IN THE PATIENTS ARTERY. PATIENT WENT TO OPERATING THEATRES FOR REMOVAL OF THE LINE. PT REMAINED NEUROVASCULARLY INTACT THROUGHOUT THE INCIDENT. THE PATIENT WAS COMPLIANT, NOT AGITATED OR MOVING WRIST EXCESSIVELY. THE ARTERIAL WAVEFORM WAS ADEQUATE AND NO SIGN OF DAMPING LEADING UP TO THE ARTERIAL LINE SNAPPING.

Additional Manufacturer Narrative

ACCORDING TO THE PRODUCT EXPERIENCE REPORT, THERE WAS NO SAMPLE TO BE RETURNED. ADDITIONALLY, NO PHOTOGRAPHIC OR VISUAL EVIDENCE OF ANY KIND WAS PROVIDED WHICH WOULD HAVE ALLOWED FOR THE ALLEGATION TO BE REVIEWED. WITHOUT SUCH EVIDENCE, THIS COMPLAINT COULD NOT BE CONFIRMED AND DETERMINING A DEFINITE ROOT CAUSE AND CORRECTIVE ACTION IS NOT POSSIBLE. IF THE SAMPLE IS RETURNED AT A FUTURE DATE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

A REVIEW OF THE DHR AND INSPECTION RECORDS WAS CONDUCTED FOR THE SPECULATED LOT NUMBER 11445670, AND NO SIMILAR CONCERNS WERE FOUND. ACCORDING TO THE CUSTOMER, THERE WAS NO SAMPLE AVAILABLE FOR REVIEW. ADDITIONALLY, NO PHOTOGRAPHIC OR VISUAL EVIDENCE OF ANY KIND WAS PROVIDED FOR THIS COMPLAINT WHICH WOULD HAVE ALLOWED FOR THE ALLEGATION TO BE REVIEWED. WITHOUT SUCH EVIDENCE, THE RESULTS ARE INCONCLUSIVE AND DETERMINING A DEFINITE ROOT CAUSE AND CORRECTIVE ACTION IS NOT POSSIBLE.

Description of Event or Problem

A RADIAL ARTERIAL LINE WAS INSERTED IN ICU ON THE 29TH JUNE AND PT TRANSFERRED TO ICU POST OP. ARTERIAL LINE FUNCTIONING PROPERLY ¿ GOOD TRACE AND BLOOD ASPIRATION. SEPARATION OF ARTERIAL CATHETER FROM HUB REQUIRING SURGICAL REMOVAL. AT APPROXIMATELY 0200HRS ON 2/7/23 THE ARTERIAL WAVEFORM SUDDENLY DISAPPEARED. ON EXAMINATION OF THE ARTERIAL LINE HUB WAS STILL SUTURED IN AND DRESSING INTACT AND SITE WAS BLEEDING. WHEN DRESSING REMOVED IT WAS FOUND THAT THE ARTERIAL LINE HAS BROKEN. THE DISTAL PART OF THE LINE UNABLE TO BE FOUND. AN XRAY OF THE PATIENTS FOREARM WAS ATTENDED AND THE ARTERIAL LINE HAD DISLODGED IN THE PATIENTS ARTERY. PATIENT WENT TO OPERATING THEATRES FOR REMOVAL OF THE LINE. PT REMAINED NEUROVASCULARLY INTACT THROUGHOUT THE INCIDENT. THE PATIENT WAS COMPLIANT, NOT AGITATED OR MOVING WRIST EXCESSIVELY. THE ARTERIAL WAVEFORM WAS ADEQUATE AND NO SIGN OF DAMPING LEADING UP TO THE ARTERIAL LINE SNAPPING.

Additional Manufacturer Narrative

A REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS FOR THIS LOT COULD NOT BE CONDUCTED SINCE A LOT NUMBER WAS NOT PROVIDED. ACCORDING TO THE CUSTOMER, THERE WAS NO SAMPLE AVAILABLE FOR REVIEW. ADDITIONALLY, NO PHOTOGRAPHIC OR VISUAL EVIDENCE OF ANY KIND WAS PROVIDED FOR THIS COMPLAINT WHICH WOULD HAVE ALLOWED FOR THE ALLEGATION TO BE REVIEWED. WITHOUT SUCH EVIDENCE, THE RESULTS ARE INCONCLUSIVE AND DETERMINING A DEFINITE ROOT CAUSE AND CORRECTIVE ACTION IS NOT POSSIBLE.

Description of Event or Problem

A RADIAL ARTERIAL LINE WAS INSERTED IN ICU ON THE (B)(6) AND PT TRANSFERRED TO ICU POST OP. ARTERIAL LINE FUNCTIONING PROPERLY ¿ GOOD TRACE AND BLOOD ASPIRATION. SEPARATION OF ARTERIAL CATHETER FROM HUB REQUIRING SURGICAL REMOVAL. AT APPROXIMATELY 0200HRS ON (B)(6)2023 THE ARTERIAL WAVEFORM SUDDENLY DISAPPEARED. ON EXAMINATION OF THE ARTERIAL LINE HUB WAS STILL SUTURED IN AND DRESSING INTACT AND SITE WAS BLEEDING. WHEN DRESSING REMOVED IT WAS FOUND THAT THE ARTERIAL LINE HAS BROKEN. THE DISTAL PART OF THE LINE UNABLE TO BE FOUND. AN XRAY OF THE PATIENTS FOREARM WAS ATTENDED AND THE ARTERIAL LINE HAD DISLODGED IN THE PATIENTS ARTERY. PATIENT WENT TO OPERATING THEATRES FOR REMOVAL OF THE LINE. PT REMAINED NEUROVASCULARLY INTACT THROUGHOUT THE INCIDENT. THE PATIENT WAS COMPLIANT, NOT AGITATED OR MOVING WRIST EXCESSIVELY. THE ARTERIAL WAVEFORM WAS ADEQUATE AND NO SIGN OF DAMPING LEADING UP TO THE ARTERIAL LINE SNAPPING