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

Model Number DYNJ66653

Device Problem Crack (1135)

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

Event Date 02/17/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that a 20ml syringe component was noted to be broken when the pack was opened.The reporting facility indicated that there were no injuries related to the reported problem/issue at the time of the incident.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 photo and a physical sample was returned for evaluation and an approximately 2-inch crack was observed down the measurement markers on the syringe.A definitive root cause was not established, however, component damage prior to pack placement or damage due to rough handling of the pack were identified to be potential root causes.Due to the reported syringe break, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that a syringe component was broken.

• 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: 18735791
• MDR Text Key: 336865162
• Report Number: 1423395-2024-00023
• Device Sequence Number: 1
• Product Code: OEQ
• 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: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJ66653
• Device Lot Number: 20ILA090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Date Manufacturer Received: 02/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other