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

Model Number	63512
Health Effect - Clinical Code	Pain (1994)
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 not able to completely insert that catheter and void.The patient also experienced pain during insertion.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was unconfirmed.Visual evaluation noted 5 unopened antibacterial hydro personal catheters were received.No damage was noted on the exterior of the packaging.Dip line and hydrophilic coating were present.Samples were tested and the organoleptic test was performed.Lubricious coating material remained on all catheters tested after more than 10 wipes.Four catheters measured to be 14fr and one measured to be 13fr, which was found to be within specification (+/- 1fr).The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿intended use the catheter is intended for urinary bladder drainage in adult males and females requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.Efficacy of the catheter in preventing urinary tract infection during intermittent use has not been established.The device is not intended to be used as a treatment for active urinary tract infection.Please contact your physician to determine which product options are best for you, paying close attention to product warnings/ precautions and adverse reactions.Instructions for use the catheter becomes slippery when wetted with water, eliminating the need for a separate lubricant.For your added convenience, this catheter is packaged with its own sterile water.Simply release the water from its foil packet and then tip the un-opened catheter package end-to-end.The catheter acts like a magnet to attract the water and activate its slippery coating.Follow these steps for best results.Release the water.Prior to opening the sealed catheter pouch: apply pressure to the foil packet to release the water.Ensure all water is released from the foil packet.Wet the catheter: hold package with printed side up.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.Use the catheter: peel back package to expose funnel end of catheter.If desired, use the self-adhesive tape on the package to temporarily attach the pouch to any dry vertical surface.Remove catheter and use according to physician¿s instructions.".
Event or Problem Description
It was reported that the patient was not able to completely insert that catheter and void.The patient also experienced pain during insertion.No medical intervention was reported.

• Brand Name: PERSONAL CATHETER¿ INTERMITTENT CATHETER
• Common Device Name: MALE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8265047
• Report Number: 1018233-2019-00336
• Device Sequence Number: 16664574
• Product Code: MJC
• UDI-Device Identifier: 00801741069239
• UDI-Public: (01)00801741069239
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033477
• 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,Followup
• Report Date (Section B): 06/04/2019

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 Expiration Date: 05/31/2019
• Device Model Number: 63512
• Device Catalogue Number: 63512
• Device Lot Number: NGAZ2855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2019
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 01/21/2019
• Supplement Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1