MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; EXT SET, 8",MINIBORE W/ BOND SMART

Catalog Number DYNDTC5081B

Device Problem Insufficient Information (3190)

Patient Problem Extravasation (1842)

Event Date 02/21/2024

Event Type  Injury  

Manufacturer Narrative

It was reported that an extravasation occured while using the device with power injection.No additional information was provided.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

Extravasation.

• Type of Device: EXT SET, 8",MINIBORE W/ BOND SMART
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18952852
• MDR Text Key: 338271913
• Report Number: 1417592-2024-00431
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 40888277114839
• UDI-Public: 40888277114839
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: DYNDTC5081B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2024
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other