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

Catalog Number	0035380
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: FEMALE CATHETER KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7860651
• Report Number: 1018233-2018-04055
• Device Sequence Number: 19361432
• Product Code: FFH
• UDI-Device Identifier: 00801741045820
• UDI-Public: (01)00801741045820
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2019

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: 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
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 12/30/2018
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1