SL CV FOR MAQUET IAB
Received Aug 13, 2021 · Event occurred Jul 19, 2021
Report 3006260740-2021-03311 · MDR key 12318980
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Model number
N/ACatalog number
0684000472
Lot number
JUFQ8517
Product problems
- Contamination /Decontamination Problem
- Contamination /Decontamination Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED A PACKAGE WITH FOREIGN MATTER IN THE POUCH. NO OTHER INFORMATION WAS PROVIDED. THREE DEVICE SAMPLES WERE RETURNED. 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, 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 FOREIGN MATERIAL WITHIN THE KIT IS CONFIRMED AND APPEARS TO BE MANUFACTURING RELATED. THREE SEALED STATLOCK MAQUET IAB PACKAGES WERE RETURNED FOR EVALUATION. TWO PHOTOS OF THE STATLOCKS PACKAGES WERE ALSO RETURNED FOR EVALUATION. THE PHOTOS CONTAIN THREE PACKAGES WHICH CORRESPOND WHICH THE CONDITIONS OF THE RETURNED SAMPLES. THE PRODUCT INFORMATION INDICATED LOT: JUFQ8517. TWO KITS WERE OBSERVED TO CONTAIN A HARD, PLASTIC MATERIAL. THE MATERIAL WAS OBSERVED TO BE A BRITTLE PLASTIC WHEN TOUCHED. THE THIRD SEALED KIT WAS OBSERVED TO CONTAIN A HAIR. SINCE THE HAIR AND PLASTIC WERE FOUND TO BE PRESENT WITHIN A SEALED KIT, THE COMPLAINT IS CONFIRMED. BD IS WORKING CLOSELY WITH THE MANUFACTURING FACILITY TO PREVENT RECURRENCE OF THE REPORTED EVENT. A LOT HISTORY REVIEW (LHR) OF JUFQ8517 SHOWED TWO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (JUFQ8517) HAVE BEEN REPORTED FROM THE SAME FACILITY. H3 OTHER TEXT : EVALUATION FINDINGS ARE IN SECTION H.11.
Additional Manufacturer Narrative
THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF JUFQ8517 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem
IT WAS REPORTED A PACKAGE WITH FOREIGN MATTER IN THE POUCH. NO OTHER INFORMATION WAS PROVIDED.