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

Model Number	420712
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Codes	Laceration(s) (1946); 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.
Event or Problem Description
It was reported that the tip of a catheters was perfectly cut off.Also stated patient experienced bleeding and pain, felt a scraping against the patient's urethra.No medical intervention was reported.
Event or Problem Description
It was reported that the tip of a catheters was perfectly cut off.Also stated patient experienced bleeding and pain, felt a scraping against the patient's urethra.No medical intervention was reported.Per sample evaluation determined through evaluation that the tip of the catheter was not formed properly.During sample evaluation, it was determined that the cut catheter was caused because the catheter was sticking out of the packaging during sealing causing a sterile barrier breach.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing-related.Visual inspection noted one clean cath catheter was received in the original opened packaging.Visual evaluation noted the tip of the catheter was cut off, and upon further inspection the tyvek seal near the tip end of the packaging was almost complete except for one void that perfectly fit the device through it.This gives supporting evidence that the catheter wasn't loaded properly in the packaging, and the tip was cut during the sealing of the package.This fails to meet specifications stating components trapped in seal are not permitted.The eyelets were present on the device.Although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure could be not enough depth in cavity.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not performed because labeling could not have prevented the reported failure.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: CLEAN CATH VINYL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10414481
• Report Number: 1018233-2020-05250
• Device Sequence Number: 14135162
• Product Code: KOD
• UDI-Device Identifier: 00801741038730
• UDI-Public: (01)00801741038730
• 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): 11/24/2020

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: 11/30/2024
• Device Model Number: 420712
• Device Catalogue Number: 420712
• Device Lot Number: NGDY1813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1