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

Model Number	63612
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 tubing was too thick and the catheter had been cut incorrectly.It was stated that the chemist was concerned because the customer had attempted to use them.
Additional Manufacturer Narrative
Four opened hydrosil intermittent catheter were returned for evaluation.The reported event was confirmed as manufacturing related.The samples were visually inspected for holes or damage on the package, legibility of printed numbers and letters, expiration date, correct impression, print color, missing parts of printing, position of printing, damaged component, and foreign matter.The samples were opened and the catheters were trapped and cut.The samples were dimensionally evaluated for their outer diameter.Two of the samples were found out of specification.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use 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.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.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." (b)(4).
Event or Problem Description
It was reported that the tubing was too thick and the catheter had been cut incorrectly.It was stated that the chemist was concerned because the customer had attempted to use them.

• 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: 7046280
• Report Number: 1018233-2017-06016
• Device Sequence Number: 19135260
• Product Code: KOD
• UDI-Device Identifier: 00801741069284
• UDI-Public: (01)00801741069284
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K000723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2018

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: 10/28/2021
• Device Model Number: 63612
• Device Catalogue Number: 63612
• Device Lot Number: JUAX0686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Initial Date Received by Manufacturer: 11/02/2017
• Supplement Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1