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

Model Number	120614
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
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 color of the bard tiemann model coude tip 14fr intermittent catheter was lighter orange when the customer first started using it, but the catheters from the last order was more of a darker shade of orange or red.It was also stated that the darker ones seemed like the rubber was harder than the lighter one and harder to insert which seemed to cause more irritation than the lighter ones.Per additional information received via email on 14jan2022, the problem was the dark brown colored catheters seemed harder than the lighter orange colored ones causing more irritation when inserted.It was also stated that the darker colored ones also had the dimple that did not line up with the curved end, which made it more difficult to insert straight.
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 color of the bard tiemann model coude tip 14fr intermittent catheter was lighter orange when the customer first started using it, but the catheters from the last order was more of a darker shade of orange or red.It was also stated that the darker ones seemed like the rubber was harder than the lighter one and harder to insert which seemed to cause more irritation than the lighter ones.Per additional information received via email on 14jan2022, the problem was the dark brown colored catheters seemed harder than the lighter orange colored ones causing more irritation when inserted.It was also stated that the darker colored ones also had the dimple that did not line up with the curved end, which made it more difficult to insert straight.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Corrections: d, g, h.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.
Event or Problem Description
It was reported that the color of the bard tiemann model coude tip 14fr intermittent catheter was lighter orange when the customer first started using it, but the catheters from the last order was more of a darker shade of orange or red.It was also stated that the darker ones seemed like the rubber was harder than the lighter one and harder to insert which seemed to cause more irritation than the lighter ones.Per additional information received via email on 14jan2022, the problem was the dark brown colored catheters seemed harder than the lighter orange colored ones causing more irritation when inserted.It was also stated that the darker colored ones also had the dimple that did not line up with the curved end, which made it more difficult to insert straight.Per additional information via form with sample returned on (b)(6) 2022, customer had urinary tract infection using the intermittent catheter.Customer also stated that the catheters were brown in color and not in orange or red , seem harder.On some catheter the dimples did not match up with the curve on the other end.Customer concerned if they were as sterile as having more urinary tract infection than with the ones that were a different color.The brown ones seem different from the catheter which customer used the last couple of years.The curve not going right way it makes it harder to insert.No medical intervention was reported.
Event or Problem Description
It was reported that the color of the bard tiemann model coude tip 14fr intermittent catheter was lighter orange when the customer first started using it, but the catheters from the last order was more of a darker shade of orange or red.It was also stated that the darker ones seemed like the rubber was harder than the lighter one and harder to insert which seemed to cause more irritation than the lighter ones.Per additional information received via email on 14jan2022, the problem was the dark brown colored catheters seemed harder than the lighter orange colored ones causing more irritation when inserted.It was also stated that the darker colored ones also had the dimple that did not line up with the curved end, which made it more difficult to insert straight.Per additional information via form with sample returned on 09feb2022, customer had urinary tract infection using the intermittent catheter.Customer also stated that the catheters were brown in color and not in orange or red , seem harder.On some catheter the dimples did not match up with the curve on the other end.Customer concerned if they were as sterile as having more urinary tract infection than with the ones that were a different color.The brown ones seem different from the catheter which customer used the last couple of years.The curve not going right way it makes it harder to insert.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was confirmed manufacturing related.Samples were confirmed to exhibit the reported failure.A potential root cause for this failure could be "machine error".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review is not required as the reported event was found to be manufacturing related.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.

• Brand Name: BARD® URETHRAL CATHETER
• Common Device Name: URETHRAL 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: 13467459
• Report Number: 1018233-2022-00423
• Device Sequence Number: 3886760
• Product Code: KOD
• UDI-Device Identifier: 00801741029967
• UDI-Public: (01)00801741029967
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/10/2026
• Device Model Number: 120614
• Device Catalogue Number: 120614
• Device Lot Number: NGFR2541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/14/2022
• Supplement Date Received by Manufacturer: 02/09/2022; 06/10/2022
• Initial Report FDA Received Date: 02/06/2022
• Supplement Report FDA Received Date: 03/08/2022; 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2021
• 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