MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD TOUCHLESS URETHRAL CATHETER KIT WITH RED RUBBER CATHETER

Model Number	4A3053
Medical Device Problem Codes	Component Missing (2306); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
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 jelly or iodine's was missing from 12 bard touchless catheter in the last couple of months.
Event or Problem Description
It was reported that bard touchless catheter was having missing iodine's in the last couple months.Customer was using bard touchless for 18 years and this has been quite a few times but never reported it.
Additional Manufacturer Narrative
Per additional info received from investigation, bd has determined that this mdr event is not reportable.The product intentionally did not include iodine and had a warning label, the reported issue is not considered a failure and meets the definition of a customer preference complaint.Visual evaluation of the returned sample noted one opened (within original packaging), unused touchless catheter.Visual inspection of the sample noted no obvious visible defects.It was noted that only the top view of the packaging was visible, so it could not be visually confirmed that there was no iodine included.However, based on the lot number and the yellow label on the packaging, the product was intended to be sold without iodine under manufacturing waiver, so the lack of iodine in the product was intentional.H11:section a through f - 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.H3 other text : the actual/suspected device was inspected.

• Brand Name: BARD TOUCHLESS URETHRAL CATHETER KIT WITH RED RUBBER CATHETER
• Common Device Name: RED RUBBER CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10977908
• Report Number: 1018233-2020-21550
• Device Sequence Number: 16725160
• Product Code: FCM
• UDI-Device Identifier: 00801741030680
• UDI-Public: (01)00801741030680
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K910653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2021

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: 4A3053
• Device Catalogue Number: 4A3053
• Device Lot Number: NGCR4557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 05/28/2021
• 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