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

Model Number	INTL16C
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the intermittent coude catheter kit with the bag attached was used and patient had over 1000 ml in the bladder as per scan but when customer inserted the catheter, nothing drained.They troubleshooted for a bit and finally removed the catheter.Upon examination, the tip of the catheter has no fenestrations or holes to allow the urine to drain.Per additional information received via sample form on 07jun2022, it was reported that the patient catheterized but no urine returned even though volume was greater than 1000 ml.After catheter was removed and inspection noted that there were no fenestrations or holes at the tip of the catheter for urine to drain.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bd 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 bd.
Additional Manufacturer Narrative
The reported event is confirmed, manufacturing related.The coude intermittent catheter with attached drainage bag was returned opened with the original packaging.The catheter was visually inspected and no drainage eyes were present on the catheter.The catheter does not meet specifications.The coude tip was observed to be aligned with the coude indicator, and no lumps or damages were noted on the catheter.A potential root cause for this event could be, "operator error".The device was attempted to be used for treatment purposes.The lot number was unknown; therefore, the device history record could not be reviewed.A label/pack review is not required as a review of the label could not have prevented the reported event.The actual/suspected device was inspected.
Event or Problem Description
It was reported that the intermittent coude catheter kit with the bag attached was used and patient had over 1000 ml in the bladder as per scan but when customer inserted the catheter, nothing drained.They troubleshooted for a bit and finally removed the catheter.Upon examination, the tip of the catheter has no fenestrations or holes to allow the urine to drain.Per additional information received via sample form on 07jun2022, it was reported that the patient catheterized but no urine returned even though volume was greater than 1000 ml.After catheter was removed and inspection noted that there were no fenestrations or holes at the tip of the catheter for urine to drain.

• 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: 14676187
• Report Number: 1018233-2022-04566
• Device Sequence Number: 5410471
• Product Code: KOD
• UDI-Device Identifier: 00801741029974
• UDI-Public: (01)00801741029974
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 10/10/2022
• 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: Health Professional
• Device Model Number: INTL16C
• Device Catalogue Number: 120616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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