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

Model Number	63616
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "1.Release the water prior to opening the sealed catheter pouch: a.Apply pressure to the foil packet to release the water.B.Ensure all water is released from the foil packet.2.Wet the catheter a.Hold package with printed side up.B.Tip package end-to-end three to six times to wet catheter.This movement is required so that the water transfers back and forth over the catheter to fully wet the hydrophilic coating.3.Use the catheter a.Peel back package to expose funnel end of catheter.B.If desired, use the self-adhesive tape on the package to temporarily attach the pouch to any dry vertical surface.C.Remove catheter and use according to physician¿s instructions.Warning: this is a single use device.Do not reuse.Reuse of a single use device increases the risk of catheter acquired urinary tract infections."the device was not returned.
Event or Problem Description
It was reported that the eyelets on the intermittent hydro male catheter were not smooth and had ridges around the catheter.No medical intervention was reported.

• Brand Name: PERSONAL CATHETER¿ INTERMITTENT CATHETER
• Common Device Name: INTERMITTENT HYDRO MALE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8217900
• Report Number: 1018233-2019-00113
• Device Sequence Number: 1631282
• Product Code: KOD
• UDI-Device Identifier: 00801741069307
• UDI-Public: (01)00801741069307
• 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): 01/04/2019

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: 63616
• Device Catalogue Number: 63616
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2018
• Initial Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1