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

Model Number	421716
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
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.
Event or Problem Description
It was reported that the tip of the catheter broke off inside of the patient.The patient was seen in the emergency room where an x-ray and a probe were performed, however, the tip of the catheter could not be located or retrieved.The patient had to schedule a pending appointment to follow up with the urologist in a week.
Additional Manufacturer Narrative
The reported event was confirmed.Visual evaluation of the sample noted one used clean cath vinyl intermittent catheter without original packaging.It was noted that the catheter was broken with a jagged edge and a portion of the tip missing.A catheter with a missing tip did not conform and was out of specification.Although the reported event was confirmed, the root cause could not be determined.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.
Event or Problem Description
It was reported that the tip of the catheter broke off inside of the patient.The patient was seen in the emergency room where an x-ray and a probe were performed, however, the tip of the catheter could not be located or retrieved.The patient had to schedule a pending appointment to follow up with the urologist in a week.

• Brand Name: BARD® CLEAN-CATH® INTERMITTENT CATHETER
• Common Device Name: CLEAN VINYL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9521685
• Report Number: 1018233-2019-08246
• Device Sequence Number: 2851565
• Product Code: KOD
• UDI-Device Identifier: 00801741038839
• UDI-Public: (01)00801741038839
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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: Lay User/Patient
• Device Expiration Date: 06/30/2024
• Device Model Number: 421716
• Device Catalogue Number: 421716
• Device Lot Number: NGDT1462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 02/10/2020
• 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: Other