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	02/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the color of the intermittent catheter was light orange when the patient started to use it but the catheter from the last order was more of a darker shade of orange and red.Patient stated that the darker catheter's rubber was harder than the lighter one and seemed harder to insert which seemed to cause more irritation than the lighter one.Per additional information received via email on 14jan2022, the problem was that 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 catheters ((b)(4)).Customer also stated that the catheters were brown in color and not in orange or red ((b)(4)), and seems harder ((b)(4)).On some catheter the dimples did not match up with the curve on the other end ((b)(4)).Customer was 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 the right way makes it harder to insert.No medical intervention was reported.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
The reported event was confirmed manufacturing related.Samples were confirmed to exhibit the reported failure.As the reported event was found to be manufacturing related, it is deemed to fail to meet specifications.As the products were unopened they were not used for diagnostic or treatment purposes, but are intended for treatment.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.Correction: g,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.
Event or Problem Description
It was reported that the color of the intermittent catheter was light orange when the patient started to use it but the catheter from the last order was more of a darker shade of orange and red.Patient stated that the darker catheter's rubber was harder than the lighter one and seemed harder to insert which seemed to cause more irritation than the lighter one.Per additional information received via email on (b)(6)2022, the problem was that 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 catheters (ngfp3267 and ngfr2541).Customer also stated that the catheters were brown in color and not in orange or red (ngfp3267 and ngfr2541), and seems harder (ngfp3267 and ngfr2541).On some catheter the dimples did not match up with the curve on the other end (ngfp3267 and ngfr2541).Customer was 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 the right way makes it harder to insert.No medical intervention was reported.

• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13693657
• Report Number: 1018233-2022-01124
• Device Sequence Number: 20126403
• 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
• Report Date (Section B): 06/16/2022

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: Lay User/Patient
• Device Expiration Date: 01/10/2026
• Device Model Number: 120614
• Device Catalogue Number: 120614
• Device Lot Number: NGFP3267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2021
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Race: White