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

Model Number	802416
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing-related.One sample was confirmed to exhibit the reported failure.7 red rubber catheter were returned opened in original packaging.No obvious defects were noted.The catheter eyes were measured for each catheter using a caliper.The distance from tip to eye center for each catheter was measured and found to meet specification.The catheter eye widths were found to meet specification.The eyes for catheter 3 and 4 were found to be too long and did not meet specification.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.Labeling review was not required as the reported event was confirmed as manufacturing related.
Event or Problem Description
It was reported that occasionally there was one red rubber intermittent catheter that had smaller diameter, softer and more flexible and were hence not usable for the customer as the rigidity needed was not that of the usual size.In the past few months, customer noted that the number of these different catheters were on the rise.Customer stated that 9 catheters were found in a box of 100.Customer also stated that the difference was clear both to visual inspection and to feel.Per follow up on (b)(6) 2021, customer had occasional thin-walled, smaller diameter one in a box of 100.The current box of 100 that the customer was about to finish had 38 of the thinner ones in it.

• Brand Name: BARDIA® 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: 12885551
• Report Number: 1018233-2021-07575
• Device Sequence Number: 11749421
• Product Code: KOD
• UDI-Device Identifier: 00801741018367
• UDI-Public: (01)00801741018367
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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
• Report Date (Section B): 11/23/2021

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: 01/31/2025
• Device Model Number: 802416
• Device Catalogue Number: 802416
• Device Lot Number: NGEV1423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2020
• 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