MAUDE Adverse Event Report: COVIDIEN 3/10CC INS SAFETY SYR 30X5/16; SYRINGE, PISTON

Model Number 8881511344

Device Problem Malposition of Device (2616)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Customers reported that the safety hub is in the way and will not work.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was release accomplishing all quality standards.The manufacturing site was provided with one representative photograph from the customer.In the photograph provided, a single unpackaged syringe can be observed.There is a closeup image of a syringe with safety hub intact.The hub appears to extend slightly past the base of the needle where it is secured to the needle.It is unknown as to the functionality of the device.The manufacturing site did not receive any physical samples with this customer report.Without a representative sample(s) being provided, a more complete investigation cannot be performed to the full extent and the reported condition cannot be confirmed.In addition, without sample, a root cause cannot be determined at this time.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.

• Brand Name: 3/10CC INS SAFETY SYR 30X5/16
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 8811451
• MDR Text Key: 151721352
• Report Number: 1915484-2019-01064
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 20884521015040
• UDI-Public: 20884521015040
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881511344
• Device Catalogue Number: 8881511344
• Device Lot Number: 912222X
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1