MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-GU LAPAROSCOPY PACK

Model Number DYNJ60045

Device Problem Volume Accuracy Problem (1675)

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

Event Date 03/06/2019

Event Type  malfunction  

Event Description

It was reported that a syringe component was not measuring accurately.

Manufacturer Narrative

It was reported that a 10ml syringe component was not measuring 10ml.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.No sample was returned for evaluation.The reported problem/issue was unable to be confirmed and a 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.

• Type of Device: DBD-GU LAPAROSCOPY 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: 18896747
• MDR Text Key: 337582636
• Report Number: 1423395-2024-00345
• Device Sequence Number: 1
• Product Code: OHD
• 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: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJ60045
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other