MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR ENSPIRE CASSETTE; BIOPSY DISPOSABLE

Catalog Number	DS4001
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device was not returned.The investigation is currently under way.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.
Event or Problem Description
It was reported that during preparation for a biopsy, the individual cassette package was allegedly found with the sterile wrapping opened.It was further reported that another device was used perform the procedure.There was no reported patient contact.
Additional Manufacturer Narrative
The device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.A physical sample was not returned for evaluation, however, four electronic photos were provided for review.The first photo shows the device packaging with the label side up.It was noted that the entirety of the packaging cannot be seen, it is unknown whether the packaging is breached.Photo two, three, and four show the packaging being held together with a piece of tape.It is unknown when or why the tape was placed onto the packaging.Therefore, the investigation is inconclusive for the reported breach of sterile barrier based on the photo review.Per the reported event details, the product is received into the facility and processed from the edc in full packs and sent out in singles as requested.The product is stored at the facility either in a full box or singles and all product is wrapped in plastic to protect it from dust, etc.Although it is likely the storage practices at the facility may have contributed to the reported breach of sterile barrier, the definitive root cause could not be determined based upon the provided information.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
Event or Problem Description
It was reported that during preparation for a biopsy, the individual cassette package was allegedly found with the sterile wrapping opened.It was further reported that another device was used to perform the procedure.There was no reported patient contact.

• Brand Name: ENCOR ENSPIRE CASSETTE
• Common Device Name: BIOPSY DISPOSABLE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7404045
• Report Number: 2020394-2018-00348
• Device Sequence Number: 16693312
• Product Code: KNW
• UDI-Device Identifier: 00801741086090
• UDI-Public: (01)00801741086090
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K111100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2018

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 Catalogue Number: DS4001
• Device Lot Number: VTBP0085
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 06/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1