MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PERSONAL CATHETER INTERMITTENT CATHETER

Model Number	62608
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
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 the water packet for the intermittent catheter was missing.
Event or Problem Description
It was reported that the water packet for the intermittent catheter was missing.
Additional Manufacturer Narrative
The reported event was inconclusive.It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.No sample was returned for evaluation.A potential root cause for this failure could be due to "lack of operator training".The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labelling could not have prevented the reported failure.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 device was not returned.

• Brand Name: PERSONAL CATHETER INTERMITTENT CATHETER
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11695503
• Report Number: 1018233-2021-02222
• Device Sequence Number: 14226952
• Product Code: KOD
• UDI-Device Identifier: 00801741069130
• UDI-Public: (01)00801741069130
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K000723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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: 06/28/2022
• Device Model Number: 62608
• Device Catalogue Number: 62608
• Device Lot Number: JUBU0442
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 06/25/2021
• 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