MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 32MM 30BX

Catalog Number 35303

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that several of the sheath packets in the stock were completely empty.There was no patient involvement.

Manufacturer Narrative

The device was not returned for evaluation.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: "remove sheath from its wrapping." 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.H3 other text : the device was not returned.

Event Description

It was reported that several of the sheath packets in the stock were completely empty.There was no patient involvement.

Manufacturer Narrative

Upon further review, bard medical/bd has determined that this mdr was initially reported in error as this event is not reportable.

Event Description

It was reported that several of the sheath packets in the stock were completely empty.There was no patient involvement.

• Brand Name: ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 32MM 30BX
• Type of Device: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8249524
• MDR Text Key: 133204176
• Report Number: 1018233-2019-00266
• Device Sequence Number: 1
• Product Code: NNX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2023
• Device Catalogue Number: 35303
• Device Lot Number: JUCU0256
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1