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

Model Number	63614
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Injury (2348); Patient Problem/Medical Problem (2688)
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 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.The device was not returned.
Event or Problem Description
It was reported that there were sharp edges on the catheter which scratched and scraped the urethra during removal of the catheter.There was self-limited bleeding that occurred however; no medical intervention was required.
Event or Problem Description
It was reported that there were sharp edges on the catheter which scratched and scraped the urethra during removal of the catheter.There was self-limited bleeding that occurred however; no medical intervention was required.
Additional Manufacturer Narrative
The reported event was unconfirmed.Visual evaluation noted 5 unopened samples returned.Samples were opened and inspected.No sharp edge, protrusions on the shaft, tip, or eyelets were noted.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 patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.Please contact your physician to determine which product options are best for you, paying close attention to product warnings/ precautions and adverse reactions.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.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.Precautions: urethral catheter for urological use only.Discard after use, do not resterilize.Made of silicone elastomer.".

• Brand Name: PERSONAL CATHETER¿ INTERMITTENT CATHETER
• Common Device Name: MALE INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7716312
• Report Number: 1018233-2018-03013
• Device Sequence Number: 19270936
• Product Code: KOD
• UDI-Device Identifier: 00801741069291
• UDI-Public: (01)00801741069291
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

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: 01/28/2022
• Device Model Number: 63614
• Device Catalogue Number: 63614
• Device Lot Number: JUBP0227A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Initial Date Received by Manufacturer: 07/06/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1