STATLOCK ARTERIAL PLUS CRESCENT TRICOT BND STOPCOCK ALC PREP 500 BOX

Additional Manufacturer Narrative

H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE ANALYSIS, APPLICABLE FMEA DOCUMENTS, APPLICABLE MANUFACTURING RECORDS, AND LABELING. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A HUB DETACHMENT IS CONFIRMED BUT THE EXACT CAUSE REMAINS UNKNOWN. ONE STATLOCK EXTENSION SET WITH A 3-WAY STOPCOCK ATTACHED TO THE HUB WAS RETURNED FOR EVALUATION. A PHOTO OF A STATLOCK EXTENSION SET WAS ALSO PROVIDED AND CORRESPONDED WITH THE RETURNED PHYSICAL SAMPLE. THE SAMPLE WAS RETURNED WITH AN ARROW RADIAL ARTERY CATHETERIZATION KIT LABEL WITH PN: ASK-04020-LHC AND LN:13F21C0259. THE SAMPLE WAS RETURNED WITH THE HUB DETACHED FROM THE EXTENSION TUBING. TACTILE EVALUATION OF THE EXTENSION TUBING DID NOT REVEAL ANY EVIDENCE OF TENSILE WEAKNESS. THE EXTENSION TUBING WITH THE OVER-SLEEVE WAS ABLE TO BE INSERTED WITHIN THE HUB WITH A TIGHT FIT. THE OUTER DIAMETER OF THE EXTENSION TUBING OVER-SLEEVE WAS MEASURED AND WAS FOUND TO BE WITHIN MANUFACTURING SPECIFICATION. MICROSCOPIC OBSERVATION OF THE EXTENSION TUBING DID NOT REVEAL ANY EVIDENCE OF A BREAK OR SPIT IN THE MATERIAL. BASED ON THE CONDITION OF THE RETURNED SAMPLE, POSSIBLE CONTRIBUTING FACTORS INCLUDE INSUFFICIENT ADHESIVE AND EXPOSURE TO TENSILE FORCES DURING HANDLING. THIS IS THE ONLY REPORTED COMPLAINT FOR THE LOT NUMBER PROVIDED. A REVIEW OF THE MANUFACTURING RECORDS AND QUALITY CONTROLS DID NOT REVEAL ANY EVIDENCE TO SUGGEST A MANUFACTURING RELATED ROOT CAUSE; HOWEVER, AN AWARENESS TRAINING WAS PERFORMED WITH THE APPROPRIATE MANUFACTURING PERSONNEL REGARDING THIS ISSUE. SINCE THE HUB WAS FOUND TO HAVE BEEN DETACHED FROM THE EXTENSION TUBING, THE COMPLAINT IS CONFIRMED BUT THE EXACT CONTRIBUTING FACTORS REMAIN UNKNOWN.

Description of Event or Problem

IT WAS REPORTED THAT THE CUSTOMER RETURNED ONE ANCHORING DEVICE AND LIDSTOCK FOR EVALUATION. SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL WERE PRESENT IN THE HUB AND TUBING. VISUAL INSPECTION OF THE DEVICE REVEALED THE LUER HUB HAD DISCONNECTED FROM THE TUBING OF THE DEVICE. ADD INFO RCVD 07/28/2021: NO PT INJURY/ DATE OF OCCURRENCE: (B)(6) 2021. PLACEMENT DATE: (B)(6) 2021. EXPLANT DATE: (B)(6) 2021.

Additional Manufacturer Narrative

THE MANUFACTURER HAS RECEIVED THE SAMPLE AND IS PENDING EVALUATION. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF JUET0118 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

Description of Event or Problem

IT WAS REPORTED THAT THE CUSTOMER RETURNED ONE ANCHORING DEVICE AND LIDSTOCK FOR EVALUATION. SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL WERE PRESENT IN THE HUB AND TUBING. VISUAL INSPECTION OF THE DEVICE REVEALED THE LUER HUB HAD DISCONNECTED FROM THE TUBING OF THE DEVICE ADD INFO RCVD 07/28/2021: NO PT INJURY DATE OF OCCURRENCE: (B)(6) 2021. PLACEMENT DATE: (B)(6) 2021. EXPLANT DATE: (B)(6) 2021.