BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER
Report
- Report Number
- 1018233-2024-03826
- Event Type
- Malfunction
- Date Received
- June 28, 2024
- Date of Event
- June 11, 2024
- Report Date
- October 17, 2024
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- KOD
- UDI-DI
- 00801741039058
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS AVAILABLE FOR EVALUATION AND FURTHER INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS. ROOT CAUSE COULD NOT BE IDENTIFIED. ALTHOUGH A ROOT CAUSE COULD NOT BE DEFINITIVELY IDENTIFIED, BASED ON THE RISK DOCUMENTATION REVIEW, A POTENTIAL ROOT CAUSE FOR THIS TYPE OF FAILURE COULD BE "OPERATOR ERROR". HOWEVER, THERE WAS INSUFFICIENT INFORMATION TO CONFIRM THIS POTENTIAL ROOT CAUSE. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A LABELING REVIEW WAS NOT PERFORMED BECAUSE LABELING COULD NOT HAVE PREVENTED THE REPORTED FAILURE. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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 REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS AVAILABLE FOR EVALUATION AND FURTHER INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS. ROOT CAUSE COULD NOT BE IDENTIFIED. ALTHOUGH A ROOT CAUSE COULD NOT BE DEFINITIVELY IDENTIFIED, BASED ON THE RISK DOCUMENTATION REVIEW, A POTENTIAL ROOT CAUSE FOR THIS TYPE OF FAILURE COULD BE "OPERATOR ERROR". HOWEVER, THERE WAS INSUFFICIENT INFORMATION TO CONFIRM THIS POTENTIAL ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. A LABELING REVIEW WAS NOT PERFORMED BECAUSE LABELING COULD NOT HAVE PREVENTED THE REPORTED FAILURE. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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.
IT WAS REPORTED THAT THEY GOT TWO RETURNS OF INTERMITTENT CATHETERS ONE FOR 802516 AND ANOTHER FOR 802514. THE PATIENT WITH MATERIAL# 802514 SAID THE ENDS WERE TOO BIG ON THEIR SHIPMENT WITH LOT# NGGT5344. THE PATIENT WITH MATERIAL# 802516 SAID THAT THE CATHETER CAME TO THEM WERE SUPER THICK AND THEY SENT BACK CATHETER WITH LOT# NGGU0960, COMPARED TO WHAT THEY CURRENTLY HAVE IN THE SLOT LOT# NGHY2643. THE COLOR WAS NOTICEABLY DIFFERENT SO IT WAS POSSIBLE IT COULD BE A DIFFERENT FORM OF RUBBER. THE DARKER RED THEY SENT BACK HAD AN EXPIRATION OF 28FEB2027 AND THEY NOTICED THE EYELET WAS SMALLER ON THE DARKER ONE. THE ONES THEY CURRENTLY HAD WERE A LIGHTER RED WITH EXPIRATION OF 30APR2028 SO WHATEVER THEY RECEIVED WAS AN OLDER MANUFACTURE DATE, SO IT WAS POSSIBLE BARD HAD CHANGED SOMETHING AND AGAIN IT DID APPEAR THE EYELET HOLE WAS BIGGER ON THE LIGHTER COLOR.
IT WAS REPORTED THAT THEY GOT TWO RETURNS OF INTERMITTENT CATHETERS ONE FOR 802516 AND ANOTHER FOR 802514. THE PATIENT WITH MATERIAL# 802514 SAID THE ENDS WERE TOO BIG ON THEIR SHIPMENT WITH LOT# NGGT5344. THE PATIENT WITH MATERIAL# 802516 SAID THAT THE CATHETER CAME TO THEM WERE SUPER THICK AND THEY SENT BACK CATHETER WITH LOT# NGGU0960, COMPARED TO WHAT THEY CURRENTLY HAVE IN THE SLOT LOT# NGHY2643. THE COLOR WAS NOTICEABLY DIFFERENT SO IT WAS POSSIBLE IT COULD BE A DIFFERENT FORM OF RUBBER. THE DARKER RED THEY SENT BACK HAD AN EXPIRATION OF 28FEB2027 AND THEY NOTICED THE EYELET WAS SMALLER ON THE DARKER ONE. THE ONES THEY CURRENTLY HAD WERE A LIGHTER RED WITH EXPIRATION OF 30APR2028 SO WHATEVER THEY RECEIVED WAS AN OLDER MANUFACTURE DATE, SO IT WAS POSSIBLE BARD HAD CHANGED SOMETHING AND AGAIN IT DID APPEAR THE EYELET HOLE WAS BIGGER ON THE LIGHTER COLOR. PER CUSTOMER VIA EMAIL RESPONSE ON 24JUN2024, IT WAS REPORTED THAT THE PRODUCT WAS USED ON A PATIENT AND THE DEFECT WAS ALSO NOTICED BEFORE USE. NO PATIENT HARM WAS REPORTED. IT WAS UNKNOWN WHETHER THE CATHETER AND EYELET DIMENSIONS WERE UNDER SPECIFICATION. THE MATERIAL WAS TOO THICK, AND RIGID COMPARED TO OTHER LOTS.
IT WAS REPORTED THAT THEY GOT TWO RETURNS OF INTERMITTENT CATHETERS ONE FOR 802516 AND ANOTHER FOR 802514. THE PATIENT WITH MATERIAL# 802514 SAID THE ENDS WERE TOO BIG ON THEIR SHIPMENT WITH LOT# NGGT5344. THE PATIENT WITH MATERIAL# 802516 SAID THAT THE CATHETER CAME TO THEM WERE SUPER THICK AND THEY SENT BACK CATHETER WITH LOT# NGGU0960, COMPARED TO WHAT THEY CURRENTLY HAVE IN THE SLOT LOT# NGHY2643. THE COLOR WAS NOTICEABLY DIFFERENT SO IT WAS POSSIBLE IT COULD BE A DIFFERENT FORM OF RUBBER. THE DARKER RED THEY SENT BACK HAD AN EXPIRATION OF 28FEB2027 AND THEY NOTICED THE EYELET WAS SMALLER ON THE DARKER ONE. THE ONES THEY CURRENTLY HAD WERE A LIGHTER RED WITH EXPIRATION OF 30APR2028 SO WHATEVER THEY RECEIVED WAS AN OLDER MANUFACTURE DATE, SO IT WAS POSSIBLE BARD HAD CHANGED SOMETHING AND AGAIN IT DID APPEAR THE EYELET HOLE WAS BIGGER ON THE LIGHTER COLOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 828843 | BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER | URETHRAL FOLEY CATHETER | KOD | C.R. BARD, INC. (COVINGTON) -1018233 | NGGU0960 | 00801741039058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |