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

Model Number	277710
Medical Device Problem Codes	Naturally Worn (2988); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
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 many of the foley catheters were discolored, cracked, and had odd scratches on them.Customer had probably 50 or more catheters on their desk with this issue of various sizes and models and all of them were within their expiration dates.Two of the worst catheters were pcn# 010120 had turned completely brown and spotty and the pcn# (b)(4) had white cracks in various places on the catheter.
Event or Problem Description
It was reported that many of the foley catheters were discolored, cracked, and had odd scratches on them.The customer had probably 50 or more catheters on their desk with this issue of various sizes and models, and all of them were within their expiration dates.Two of the worst catheters were pcn# (b)(4) had turned completely brown and spotty, and the pcn# 277710 had white cracks in various places on the catheter.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.A total of 10 unopened all-purpose catheters were returned.All 10 catheters were noted to have signs of degradation due to oxidation along of the shaft, around the eyelets and on the funnel of the catheter, it is unknown when the oxidation occurred or how the catheter was being stored.All 10 catheters were confirmed to be 11 fr.With a french gauge.A smooth lump was present on the shaft of catheter 1, however, this did not affect the acceptable french size of the catheter and was within specifications which states, "smooth lumps no larger than two french sizes are allowed on shaft." 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." "storage: store catheters at room temperature away from direct exposure to light, preferably in the original box." "keep away from sunlight" correction: f, h.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 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: 16283856
• Report Number: 1018233-2023-00557
• Device Sequence Number: 17363723
• Product Code: KOD
• UDI-Device Identifier: 00801741034084
• UDI-Public: (01)00801741034084
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

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: 10/31/2023
• Device Model Number: 277710
• Device Catalogue Number: 277710
• Device Lot Number: NGDV0062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2019
• 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