MAUDE Adverse Event Report: PRODUCTOS MEDLINE S.A. DE C.V.; RR-FAT GRAFTING PACK

Model Number DYNDA2792

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/12/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that the black rubber tip of the syringe component plunger detached during use.The reporting facility indicated that at the time of the incident, the user had to "apply so much pressure when pushing & pulling on the plungers" of the syringe.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.Samples were returned for evaluation and no pieces of the plungers were found to be missing or broken off.The returned samples were filled with water and pushed out several times.The plungers did not stick and no pieces broke during use.The reported problem/issue was unable to be confirmed.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 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 the black rubber tip of the syringe component plunger detached during use.

• Type of Device: RR-FAT GRAFTING PACK
• Manufacturer (Section D): PRODUCTOS MEDLINE S.A. DE C.V.; blvd world trade center no.106; parque industrial oradel; nuevo laredo tamaulipas, 88285 ; MX 88285
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 18826495
• MDR Text Key: 337742731
• Report Number: 3004122598-2024-00006
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 40193489823326
• UDI-Public: 40193489823326
• 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: 03/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNDA2792
• Device Lot Number: 21BBJ965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Date Manufacturer Received: 05/12/2021
• 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