MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® RUBBER UTILITY CATHETER; INTERMITTENT CATHETER

Model Number	277710
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the catheter had a pinhole near the end which caused leakage of bladder chemotherapy (lot#nggs0456, lot#nggr2390).Customer also stated that they administer hazardous drugs via this catheter and this was a huge safety issue (lot#nggs0456, lot#nggr2390).It was also reported that there was a brown spot right where the catheter widens to the flange on the end(lot#nggs0456, lot#nggr2390).
Event or Problem Description
It was reported that the catheter had a pinhole near the end which caused leakage of bladder chemotherapy (lot#nggs0456, lot#nggr2390).On 13sep2022, customer also stated that they administer hazardous drugs via this catheter and this was a huge safety issue.Per information received on 14sep2022, the customer sent photo of the hole and the hole was the brown spot right where the catheter widen to the flange on the end.Per additional information received via email on 13oct2022, customer stated that three patients needed to be catharized a second time with a non-defective catheter in order to administer their chemotherapy.There were spill procedures implemented afterwards to clean the patient room due to the leaked chemotherapy.
Additional Manufacturer Narrative
The reported event was confirmed and the cause was unknown.A potential root cause for this event based on the risk management file could be, operator or machine error", however, there was not enough information in the event or evaluation to confirm this cause.Evaluation of the photo noted what appeared to be a pinhole on the shaft of the all purpose catheter just beneath the funnel.Unable to determine if a pinhole was also present on the packaging.The physical sample was received.The sample was returned in the original unopened packaging.The holes were noted in the packaging, however, a dark spot, possibly a pinhole, was present on the catheter shaft just beneath the funnel, it was smooth to the touch.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use." the actual/suspected device was inspected.

• Brand Name: BARD® RUBBER UTILITY CATHETER
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15475817
• Report Number: 1018233-2022-07389
• Device Sequence Number: 17647290
• Product Code: KOD
• UDI-Device Identifier: 00801741034084
• UDI-Public: (01)00801741034084
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: 277710
• Device Catalogue Number: 277710
• Device Lot Number: NGGR2390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2022
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown