STATLOCK PICC PLUS CRESCENT TRICOT FIX-POST
Received Nov 18, 2021 · Event occurred Oct 25, 2021
Report 3006260740-2021-04940 · MDR key 12839974
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Model number
N/ACatalog number
PIC0222
Lot number
JUFR1220
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THE STATLOCK EASILY DETACHED FROM THE DRESSING. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.
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, COMPLAINT AND LOT HISTORY REVIEW, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), APPLICABLE MANUFACTURE RECORDS, AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A DETACHED RETAINER IS CONFIRMED AND WAS DETERMINED TO BE MANUFACTURING RELATED. TWO PICC PLUS STATLOCK DEVICES WITH TRICOT PADS AND FIXED POSTS WERE RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION SHOWED THE RETAINER OF EACH OF THE DEVICES WAS COMPLETELY DETACHED FROM THE PAD. NO NOTABLE DAMAGE WAS OBSERVED ON THE RETAINERS OR THE PADS. THE UNDERSIDES OF THE RETAINERS WERE OBSERVED TO BE SOMEWHAT TACKY. A MICROSCOPIC OBSERVATION REVEALED ADHESIVE ON THE UNDERSIDE OF THE DETACHED RETAINERS AND WITHIN THE FIBERS OF THE TRICOT PADS; HOWEVER, IT APPEARS THAT THE ADHESIVE DID NOT CURE CORRECTLY. THE INVESTIGATION WAS FORWARDED TO THE MANUFACTURING FACILITY FOR FURTHER EVALUATION, AND BD IS WORKING CLOSELY WITH THE MANUFACTURING FACILITY TO PREVENT RECURRENCE OF THE REPORTED EVENT.
Description of Event or Problem
IT WAS REPORTED THE STATLOCK EASILY DETACHED FROM THE DRESSING. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.
Additional Manufacturer Narrative
THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF JUFR1220 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (JUFR1220) HAVE BEEN REPORTED FROM THE SAME FACILITY.