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

Model Number	277712
Medical Device Problem Codes	Material Protrusion/Extrusion (2979); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
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 latex intermittent catheter seemed to be breaking down and there were some spots that had white stripes.The health professional also stated that there was discoloration at the needle eye.Per follow up on (b)(6) 2021, it was stated that the catheters should have been red all over, but it had white stripes.It was also stated that, some had rough areas on the opposite side of the eyes, some had discoloration at the eye of the needle.It was reported that there was no patient involvement.Per follow up on (b)(6) 2021, customer stated about breaking down that the texture was rough and not smooth on the opposite side of the needle eye.The catheters were not broken but were breaking down as in losing structure.
Event or Problem Description
It was reported that the latex intermittent catheter seemed to be breaking down and there were some spots that had white stripes.The health professional also stated that there was discoloration at the needle eye.Per follow up on 27may2021, it was stated that the catheters should have been red all over, but it had white stripes.It was also stated that, some had rough areas on the opposite side of the eyes, some had discoloration at the eye of the needle.It was reported that there was no patient involvement.Per follow up on 27may2021, customer stated about breaking down that the texture was rough and not smooth on the opposite side of the needle eye.The catheters were not broken but were breaking down as in losing structure.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.One sample was confirmed to exhibit the reported failure.As the device had signs of degradation, the reported event is confirmed to have a relationship with the device.As the cause of this issue is unknown, it cannot be determined if the device met specifications.As the product was not used on a patient, it was not used for diagnostic or treatment purposes.It was confirmed per moncks qe that the white stripes, rough areas of the catheter eyes, and discoloration at the eye of the needle were caused by degradation.A red all-purpose catheter was returned unopened in original packaging.The catheter was noted to have white discoloration near the eye as well as near the funnel.White discoloration and white striped discoloration were also noted along the catheter shaft.Per moncks qe, the cause of the discoloration is oxidation of the catheter.As is it unable to determine when the oxidation occurred the reported event will be confirmed cause unknown.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: "keep away from sunlight".The actual/suspected device was inspected.

• Brand Name: BARD® RUBBER UTILITY CATHETER
• Common Device Name: UTILITY 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12028159
• Report Number: 1018233-2021-03620
• Device Sequence Number: 14520342
• Product Code: KOD
• UDI-Device Identifier: 00801741034091
• UDI-Public: (01)00801741034091
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 12/14/2021

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: 06/30/2023
• Device Model Number: 277712
• Device Catalogue Number: 277714
• Device Lot Number: NGDX1323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2019
• 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