MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; TAVI PACK

Catalog Number DYNJ62216D

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/15/2023

Event Type  Injury  

Manufacturer Narrative

According to the facility on 11/15/23 "staff was prepping patient for valve replacement, when staff snapped the prep stick" sending shards of glass onto the patient.Per the facility "patient was under anesthesia longer than necessary due to staff having to locate and remove shards of glass that had landed on and around them".Per the facility, the patient is doing well.No additional information is available.The sample was requested for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the facility on 11/15/23 "staff was prepping patient for valve replacement, when staff snapped the prep stick" sending shards of glass onto the patient.

• Type of Device: TAVI PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18256809
• MDR Text Key: 329610422
• Report Number: 1423395-2023-00076
• Device Sequence Number: 1
• Product Code: OEZ
• UDI-Device Identifier: 10195327169770
• UDI-Public: 10195327169770
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: DYNJ62216D
• Device Lot Number: 23GBL842
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other