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

Model Number	277712
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
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 (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.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error as it was found to be a cascading failure of an event previously reported.H11: section a through f - the information provided by bard represents all of 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 bard.

• 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: 12030060
• Report Number: 1018233-2021-03649
• Device Sequence Number: 1374574
• 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): 11/30/2021

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: 03/31/2023
• Device Model Number: 277712
• Device Catalogue Number: 277712
• Device Lot Number: NGEP0919
• Was Device Available for Evaluation?: No
• 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: 11/22/2021
• Initial Report FDA Received Date: 06/19/2021
• Supplement Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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