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

Model Number	431614
Medical Device Problem Code	Illegible Information (4050)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
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.The device was not returned.
Event or Problem Description
It was reported that the patient was frustrated with the lack of clear instructions and concerned running water over the catheter would render it unsterile and finds it confusing for bard to recommend use in this manner.Patient currently in hospital.Per troubleshooting the mss stated that recommended open package and run cold water into the plastic package and wait 30 seconds to activate special non-shed slippery coating.It was then suggested to speak with hospital staff about use of another catheter especially if being treated for uti.
Event or Problem Description
It was reported that the patient was frustrated with the lack of clear instructions and concerned running water over the catheter would render it unsterile and finds it confusing for bard to recommend use in this manner.Patient currently in hospital.Per troubleshooting the mss stated that recommended open package and run cold water into the plastic package and wait 30 seconds to activate special non-shed slippery coating.Suggested to speak with hospital staff about use of another catheter especially if being treated for uti.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.Potential root cause for this failure mode could be inadequate instructions/training.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "1.Wash your hands with soap and water, and wash your genitalia using either soap and water or a wet wipe.2.Open the interglidetm packaging at the funnel end by approximately 2-3 cm.Run water from the cold tap into the sachet and wait for at least 30 seconds." 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.

• Brand Name: BARD INTERGLIDE INTERMITTENT CATHETER
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10899785
• Report Number: 1018233-2020-21182
• Device Sequence Number: 14088959
• Product Code: KOD
• UDI-Device Identifier: 00801741078033
• UDI-Public: (01)00801741078033
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K951260
• 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): 07/27/2021

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: 431614
• Device Catalogue Number: 431614
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 08/20/2021
• 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