MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® CLEAN-CATH® INTERMITTENT CATHETER; VINYL CLEAN CATHETER

Model Number	421716
Health Effect - Clinical Codes	Pain (1994); Blood Loss (2597); 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 bd 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 bd.
Event or Problem Description
It was reported that approximately 1/16 of the tip of clean cath vinyl catheter was jagged and broken off.Reportedly, the patient did not realize that the tip had broken off until he examined the catheter upon removal after a painful insertion attempt.As a result, the patient experienced self-limited bleeding.When the patient attempted to cath with a second clean cath vinyl catheter, he discovered that although, the package was sealed closed there was no catheter in the package.The patient advised that he will follow-up with his doctor to make sure he is clear of any infection.
Event or Problem Description
It was reported that approximately 1/16 of the tip of clean cath vinyl catheter was jagged and broken off.Reportedly, the patient did not realize that the tip had broken off until he examined the catheter upon removal after a painful insertion attempt.As a result, the patient experienced self-limited bleeding.When the patient attempted to cath with a second clean cath vinyl catheter, he discovered that although, the package was sealed closed there was no catheter in the package.The patient advised that he will follow-up with his doctor to make sure he is clear of any infection.
Additional Manufacturer Narrative
The reported event was confirmed as supplier related.Visual inspection noted one used catheter with original packaging was received.The tip of the catheter was missing with jagged edges on the end.A potential root cause for this failure could be defective material mixed in the raw material lot from supplier.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: "visually inspect the product for any imperfections or surface deterioration prior to use." h11:section a through f - the information provided by bd 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 bd.

• Brand Name: BARD® CLEAN-CATH® INTERMITTENT CATHETER
• Common Device Name: VINYL CLEAN CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8586017
• Report Number: 1018233-2019-02340
• Device Sequence Number: 2169667
• Product Code: KOD
• UDI-Device Identifier: 00801741038839
• UDI-Public: (01)00801741038839
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K802665
• 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): 07/15/2019

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: 11/30/2023
• Device Model Number: 421716
• Device Catalogue Number: 421716
• Device Lot Number: NGCY3128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1