DILATION PRODUCTS
Report
- Report Number
- 1018233-2023-08736
- Event Type
- Malfunction
- Date Received
- December 5, 2023
- Date of Event
- November 27, 2023
- Report Date
- December 11, 2023
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- FBW
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO "INADEQUATE MATERIAL SELECTION". THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. THE PRODUCT CATALOG NUMBER AND THE LOT NUMBER FOR THIS DEVICE ARE UNKNOWN. THEREFORE, BD IS UNABLE TO DETERMINE THE ASSOCIATED LABELING TO REVIEW. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.
IT WAS REPORTED THAT THE FOLEY CATHETER WOULD NOT DRAIN. NO DIFFICULTY WITH INSERTION BUT WHEN PRIMARY REGISTER NURSE ATTEMPTED TO DRAIN FOLEY CATHETER FROM DEPENDENT DRAIN BAG (NOT CLEAR MEASURED COLLECTION UNIT) THE SEAL ON THE WHITE SIDE AND CLEAR SIDE OF THE BAG WAS FUSED AND WOULD NOT ALLOW FOR DRAINAGE FROM DRAIN BAG. FOLEY REMAINED IN PLACE UNTIL DELIVERY UPON WHICH TIME IT WAS REMOVED WHEN PATIENT BEGAN PUSHING. NO HARM TO PATIENT OR BABY AS FOLEY WAS IN PLACE FOR A SHORT PERIOD OF TIME (LOT#NGHV3874 ). PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 28NOV2023, CUSTOMER REPORTED THAT FOLEY CATHETER HAD A DEFECT (LOT#NGHU2373 ). CERVICAL DILATION BALLOON PLACED ON (B)(6) 2023 AT 1833. CERVICAL DILATION BALLOON FOUND TO BE RUPTURED AND DEFLATED UPON ASSESSMENT. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 30NOV2023, CUSTOMER REPORTED TWO COMPLAINTS ABOUT FOLEY CATHETERS. BOTH COMPLAINTS WERE REGARDING A FOLEY BAG BEING FUSED TOGETHER (CLEAR PLASTIC PART AND WHITE PLASTIC PART) WHICH WOULD NOT ALLOW URINE TO FILL THE ENTIRE BAG (PCN#-153204 - LOT#NGHV3874 AND PCN#153204 - LOT#NGHV3874 ).
IT WAS REPORTED THAT THE FOLEY CATHETER WOULD NOT DRAIN. NO DIFFICULTY WITH INSERTION BUT WHEN PRIMARY REGISTER NURSE ATTEMPTED TO DRAIN FOLEY CATHETER FROM DEPENDENT DRAIN BAG (NOT CLEAR MEASURED COLLECTION UNIT) THE SEAL ON THE WHITE SIDE AND CLEAR SIDE OF THE BAG WAS FUSED AND WOULD NOT ALLOW FOR DRAINAGE FROM DRAIN BAG. FOLEY REMAINED IN PLACE UNTIL DELIVERY UPON WHICH TIME IT WAS REMOVED WHEN PATIENT BEGAN PUSHING. NO HARM TO PATIENT OR BABY AS FOLEY WAS IN PLACE FOR A SHORT PERIOD OF TIME (LOT#NGHV3874). PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2023, CUSTOMER REPORTED THAT FOLEY CATHETER HAD A DEFECT (LOT#NGHU2373). CERVICAL DILATION BALLOON PLACED ON(B)(6) 2023 AT 1833. CERVICAL DILATION BALLOON FOUND TO BE RUPTURED AND DEFLATED UPON ASSESSMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2197274 | DILATION PRODUCTS | DILATION PRODUCTS | FBW | C.R. BARD, INC. (COVINGTON) -1018233 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |