MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED RUBBER URETHRAL CATHETER KIT

Model Number	4A7044
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
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 one touchless plus coude tip intermittent catheter from a box of 50 had no lube in it, it was not like the lube was dried out and it was that none was added (lot# ngfs1953).It was stated that 7 each from a box of 50 had the whole tip curved over or folded in half and it was unusable (lot# ngft2379).It was also stated that 8 each from a box of 50 had the whole tip curved over or folded in half and it was unusable (lot# ngfq1655).Per additional information on (b)(6) 2021, it was stated that 2 each from of a box of 50 had the whole tip curved over or folded in half and it was unusable (lot# ngfr2863).
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.1 sample was confirmed to exhibit the reported failure.A photo sample was returned of an orange coude tip catheter as part of a urethral catheter kit.The photo sample showed that the catheter tip was folded due to being weak.As the physical sample was not available, the cause of the weak tip is unable to be determined.Unable to determine is the catheter met specifications, based on the photo sample.The reported event will be confirmed cause unknown.A potential root cause for this failure could be "operator 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 is unlikely to be caused by the user.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.H3 other text : the actual/suspected device was evaluated.
Event or Problem Description
It was reported that one touchless plus coude tip intermittent catheter from a box of 50 had no lube in it, it was not like the lube was dried out and it was that none was added (lot# ngfs1953).It was stated that 7 each from a box of 50 had the whole tip curved over or folded in half and it was unusable (lot# ngft2379).It was also stated that 8 each from a box of 50 had the whole tip curved over or folded in half and it was unusable (lot# ngfq1655).Per additional information on (b)(6)2021, it was stated that 2 each from of a box of 50 had the whole tip curved over or folded in half and it was unusable (lot# ngfr2863).

• Brand Name: BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED RUBBER URETHRAL CATHETER KIT
• 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: 12712108
• Report Number: 1018233-2021-06730
• Device Sequence Number: 11126537
• Product Code: FCM
• UDI-Device Identifier: 00801741030536
• UDI-Public: (01)00801741030536
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K910653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2022

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: 04/30/2023
• Device Model Number: 4A7044
• Device Catalogue Number: 4A7044
• Device Lot Number: NGFR2863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2021
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 05/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2021
• 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