MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 DAVOL® FEMALE CATH KIT; FEMALE CATHETER KIT

Catalog Number 0035380

Device Problems Break (1069); Material Split, Cut or Torn (4008)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.The device was not returned.

Event Description

It was reported that the female catheter kit was caught on the packing tape for the outer cardboard box resulting in a tear form the sterile packaging and a rip.

Manufacturer Narrative

The reported event was confirmed as cause unknown.The event was not a sterile barrier breach due to the presence of adhesive residue outside of the packaging, that confirmed that the tape caught onto the product and tore it, making this a post manufacturing issue.The visual evaluation of the returned sample noted one unopened, unused catheter kit.The outer package was still sealed with a 0.3510" seal width at the most narrow point, which was larger than the specification of 0.1875".However, there was a large tear in the plastic resulting in the kit being opened which was out of specification.Visible adhesive tacky residue was also visible on the exterior of the clear plastic packaging, indicative of the tape mentioned in the event description and that the package was previously sealed.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: "do not use if package is damaged.".

Event Description

It was reported that the female catheter kit was caught on the packing tape of the outer cardboard box, resulting in a tear from the sterile packaging and a rip.

• Brand Name: DAVOL® FEMALE CATH KIT
• Type of Device: FEMALE CATHETER KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7860651
• MDR Text Key: 119932447
• Report Number: 1018233-2018-04055
• Device Sequence Number: 1
• Product Code: FFH
• UDI-Device Identifier: 00801741045820
• UDI-Public: (01)00801741045820
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 0035380
• Device Lot Number: NGBV4318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Date Manufacturer Received: 12/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1