MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD INTERGLIDE INTERMITTENT CATHETER; USA INTERGLIDE 14CH FEMALE

Model Number	430614
Medical Device Problem Code	Improper Chemical Reaction (2952)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/18/2020
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 the catheters did not have any lubrication on them and so the patient had difficulty in inserting.Stated that it was very painful.Also the patient used water as instructed, but that did not help.No medical intervention was reported.
Event or Problem Description
It was reported that the catheters did not have any lubrication on them and so the patient had difficulty in inserting.Stated that it was very painful.It was also stated that the patient used water as instructed, but that did not help.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure mode could be poor coating/out of coating specifications/change in coating solution causing patient feel pain/discomfort.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: ¿interglide coated intermittent catheter sterilized using irradiation, single use, do not resterlize, federal (usa) law restricts this device to sale by or on the order of a physician.Do not use if package is damage contains or presence of phthalates.¿ correction: h.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 device was not returned.

• Brand Name: BARD INTERGLIDE INTERMITTENT CATHETER
• Common Device Name: USA INTERGLIDE 14CH FEMALE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11147540
• Report Number: 1018233-2020-22428
• Device Sequence Number: 3719127
• Product Code: KOD
• UDI-Device Identifier: 00801741077951
• UDI-Public: (01)00801741077951
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/22/2021

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: 430614
• Device Catalogue Number: 430614
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 08/16/2021
• 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