STATLOCK PICC PLUS CRESCENT SLIDING POST
Received Nov 2, 2022 · Event occurred Oct 13, 2022
Report 3006260740-2022-04264 · MDR key 15713933
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Model number
N/ACatalog number
PIC0220
Lot number
JUEP3675
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
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, COMPLAINT AND LOT HISTORY REVIEW, 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. ONE PICC PLUS STATLOCK DEVICE WITH A TRICOT PAD AND ADJUSTABLE POSTS WAS RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION SHOWED THE RIGHT SIDE OF THE RETAINER OF THE STATLOCK DEVICE WAS DETACHED FROM THE PAD. SECTIONS OF THE PAD AND THE UNDERSIDE OF THE RETAINER WERE OBSERVED TO BE TACKY. A MICROSCOPIC OBSERVATION REVEALED STRINGS OF ADHESIVE BETWEEN THE PAD AND THE RETAINER. ADHESIVE WAS OBSERVED WITHIN THE FIBERS OF THE PAD AND ON THE UNDERSIDE OF THE RETAINER; HOWEVER, IT APPEARS THAT THE ADHESIVE DID NOT CURE CORRECTLY AND/OR AN INADEQUATE AMOUNT OF PRIMER WAS APPLIED DURING THE MANUFACTURING PROCESS. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS COMPLAINT, AND BD IS WORKING CLOSELY WITH THE MANUFACTURING FACILITY TO PREVENT RECURRENCE OF THE REPORTED EVENT. H3 OTHER TEXT: EVALUATION FINDINGS ARE IN SECTION H11.
Description of Event or Problem
IT WAS REPORTED BY THE CUSTOMER "WE HAD AN INCIDENT WHERE THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM."
Additional Manufacturer Narrative
THE DATE OF EVENT WAS NOT PROVIDED BY THE COMPLAINANT/REPORTER, THE DATE REFLECTED IN THIS REPORT IS THE DATE BD BECAME AWARE OF THE EVENT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF JUEP3675 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem
IT WAS REPORTED BY THE CUSTOMER "WE HAD AN INCIDENT WHERE THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM."