MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-P V ANGIO PACK

Model Number DYNJ66653C

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2022

Event Type  malfunction  

Manufacturer Narrative

It was reported that a cracked syringe component was found within the procedural pack.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.A sample was returned for evaluation and the body of the syringe was observed to be cracked.A definitive root cause was unable to be determined.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that a cracked syringe component was found within the procedural pack.

• Type of Device: DBD-P V ANGIO PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 18921518
• MDR Text Key: 337871501
• Report Number: 1423395-2024-00142
• Device Sequence Number: 1
• Product Code: OES
• UDI-Device Identifier: 40195327033553
• UDI-Public: 40195327033553
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJ66653C
• Device Lot Number: 21LLA491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2022
• Date Manufacturer Received: 03/03/2022
• 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