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.The device was not returned.
Event or Problem Description
It was reported that (b)(4) touchless plus coude tip intermittent catheter from a box of (b)(4) 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 (b)(4) each from a box of (b)(4) had the whole tip curved over or folded in half and it was unusable (lot# ngft2379).It was also stated that (b)(4) each from a box of (b)(4) had the whole tip curved over or folded in half and it was unusable (lot# ngfq1655).Per additional information on 07oct2021, it was stated that (b)(4) each from of a box of (b)(4) had the whole tip curved over or folded in half and it was unusable (lot# ngfr2863).
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 of a box of 50 had the whole tip curved over or folded in half and it was unusable (lot: ngfq1655).Per additional information on 07oct2021, 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 inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be ¿inappropriate package design ¿.It was unknown whether the device had met specifications.Based on patient code 2645 the product does not appear to have been used.However, the product is intended to be used for treatment purpose, but it was unknown whether the product had caused the reported failure.The lot number was unknown; therefore, the device history record could not be reviewed.A labeling review was not performed because labeling could not have prevented the reported failure.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 device was not returned.

• Brand Name: BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED RUBBER URETHRAL CATHETER KIT
• Common Device Name: PRE-LUBRICATED RUBBER 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: 12605485
• Report Number: 1018233-2021-06309
• Device Sequence Number: 14307611
• 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): 12/04/2021

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: Lay User/Patient
• Device Model Number: 4A7044
• Device Catalogue Number: 4A7044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 12/04/2021
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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