STATLOCK SLIDING POST TRICOT CRESCENT PAD INCLUDES SKIN PREP
Received Feb 26, 2021 · Event occurred Feb 1, 2021
Report 3006260740-2021-00534 · MDR key 11388575
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Model number
N/ACatalog number
PIC0220CE
Lot number
JUEU0052
Product problems
- Detachment of Device or Device Component
- Loose or Intermittent Connection
- Detachment of Device or Device Component
Patient
Not reported
- 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, 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. THREE PICC PLUS STATLOCK DEVICES WITH TRICOT PADS AND ADJUSTABLE POSTS WERE RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION SHOWED USE RESIDUE ON THE RETURNED SAMPLES. THE RETAINER OF ONE SAMPLE WAS OBSERVED TO BE COMPLETELY DETACHED FROM ITS PAD, AND A MICROSCOPIC OBSERVATION REVEALED INSUFFICIENT ADHESIVE COVERAGE ON THE UNDERSIDE OF THE DETACHED RETAINER. THE RETAINERS OF THE OTHER TWO SAMPLES WERE OBSERVED TO BE INTACT, BUT THE RIGHT SIDE OF EACH OF THESE RETAINERS WAS FOUND TO DETACH SLIGHTLY FROM THE PAD WHEN A SMALL AMOUNT OF FORCE WAS APPLIED. STRINGS OF ADHESIVE WERE OBSERVED BETWEEN THE RETAINER AND THE PAD OF THESE TWO SAMPLES. 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. H3 OTHER TEXT : EVALUATION FINDINGS ARE IN SECTION H.11.
Description of Event or Problem
IT WAS REPORTED THAT WHEN "REMOVING THE PATCHES, FOR 3 PATIENTS THE LOCK GOT LOOSE." THIS REPORT ADDRESSES THE SECOND DEVICE USED.
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF JUEU0052 SHOWED TWO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (JUEU0052) HAVE BEEN REPORTED FROM THE SAME FACILITY IN THE NETHERLANDS. DEVICE NOT RETURNED FOR EVALUATION
Description of Event or Problem
IT WAS REPORTED THAT WHEN "REMOVING THE PATCHES, FOR 3 PATIENTS THE LOCK GOT LOOSE." THIS REPORT ADDRESSES THE SECOND DEVICE USED.