ARROW CONTINUOUS NERVE BLOCK KIT
Received Feb 12, 2015 · Event occurred Jan 20, 2015
Report 1036844-2015-00036 · MDR key 4523881
Device
Generic name
Anesthesia Conduction Kit
Manufacturer
Arrow Intl., Inc.Catalog number
AB-20608-KS
Lot number
23F14F0289
Product problems
- Kinked
- Material Separation
Patient
Not reported
- No Consequences Or Impact To Patient
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
THE CLINICIAN NOTICED THAT THE DISTAL END OF THE CATHETER WAS SHEARED AND APPROX 3CM OF THE SHEATHING CAME OFF THE CATHETER AND REMAINED IN THE (B)(6) 2015 AND REMOVAL OF THE CATHETER WAS ON (B)(6) 2015. NO REPORT OF PATIENT INJURY OR HARM.
Additional Manufacturer Narrative
(B)(4). ADDITIONAL INFO FROM USER FACILITY: THE PATIENT DECLINED HAVING THE FRAGMENT REMOVED AND WAS DISCHARGED FROM THE HOSP; F/U ON PATIENT CONDITION INDICATES THAT THE PATIENT HAS PAIN RELIEF AND NO REDNESS OR SWELLING AT THE CATHETER SITE. A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED BY THE CUSTOMER FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE CATHETER WITH NO RELEVANT FINDINGS. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS A POTENTIAL ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE INFO PROVIDED AND WITHOUT A SAMPLE. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE CATHETER WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THEREFORE, THE POTENTIAL CAUSE OF CATHETER SEPARATION COULD NOT BE DETERMINED BASED UPON THE INFO PROVIDED AND WITHOUT A SAMPLE.