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

Model Number	63618
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received 5 personal intermittent catheter lot samples.The reported event was unconfirmed as the product meet specifications.The exterior of the samples was visually inspected and did not find any evidence of a failure that would support the reported event.Per the functional evaluation, it was found that the volume of water in the water pack was measured and found to be within specification.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.
Event or Problem Description
It was reported that there is not enough lubricant in the water packets and the catheters felt dry.Therefore, the patient stated that he was unable to fully insert the catheters.Reason for report: investigation results.Report id number: (b)(6).Initial asr report submitted: quarter 1/2018.Corresponding exemption number: e1997042.

• Brand Name: PERSONAL CATHETER¿ INTERMITTENT CATHETER
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7750524
• Report Number: 1018233-2018-03324
• Device Sequence Number: 13745915
• Product Code: KOD
• UDI-Device Identifier: 00801741069314
• UDI-Public: (01)00801741069314
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K000723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/28/2022
• Device Model Number: 63618
• Device Catalogue Number: 63618
• Device Lot Number: JUBW0367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 08/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR