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

Model Number	4A5044
Medical Device Problem Code	Moisture Damage (1405)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
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 there was moisture present inside the sterile package.
Event or Problem Description
It was reported that there was moisture present inside the sterile package.
Additional Manufacturer Narrative
The reported event was unconfirmed because the device meets specifications.The device met relevant specifications.The product was used for treatment.The product had not caused the reported failure.Visual evaluation of the returned sample noted one opened (with original packaging), unused touchless catheter.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.As the reported event is unconfirmed a labeling review is not required.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.

• Brand Name: BARD TOUCHLESS PLUS UNISEX PRE-LUBRICATED RUBBER URETHRAL CATHETER KIT
• Common Device Name: URETHRAL CATHETER KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 12319594
• Report Number: 1018233-2021-04948
• Device Sequence Number: 16832797
• Product Code: FCM
• UDI-Device Identifier: 00801741030512
• UDI-Public: (01)00801741030512
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K910653
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2021

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: 05/31/2023
• Device Model Number: 4A5044
• Device Catalogue Number: 4A5044
• Device Lot Number: NGEW2464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other