MAUDE Adverse Event Report: BARD® CLEAN-CATH® INTERMITTENT CATHETER; VINYL CATHETER

Model Number	421714
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Tissue Damage (2104); Patient Problem/Medical Problem (2688)
Type of Reportable Event	Serious Injury
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 there was a crack on the catheter.The tip of the catheter broke inside of the patient (while still connected) during insertion, leaving a sharp edge which allegedly cut the patient.Reportedly, the catheter came out in one piece and medical intervention was required.
Additional Manufacturer Narrative
The reported event could not be confirmed as no sample was returned for evaluation.A potential failure mode could be ¿incorrect sequence¿ with a potential root cause of ¿mechanical failure¿.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use.To use: insert rounded end of catheter." 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.The device was not returned.
Event or Problem Description
It was reported that that there was a crack on the catheter.The tip of the catheter broke inside of the patient (while still connected) during insertion, leaving a sharp edge which allegedly cut the patient.Reportedly, the catheter came out in one piece and medical intervention was required.

• Brand Name: BARD® CLEAN-CATH® INTERMITTENT CATHETER
• Common Device Name: VINYL CATHETER
• MDR Report Key: 9981934
• Report Number: 1018233-2020-02744
• Device Sequence Number: 14563570
• Product Code: KOD
• UDI-Device Identifier: 00801741038822
• UDI-Public: (01)00801741038822
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K802665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 421714
• Device Catalogue Number: 421714
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/01/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention