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

Model Number	8881511344
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
Customers reported that the safety hub is in the way and will not work.
Additional 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
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 8811451
• Report Number: 1915484-2019-01064
• Device Sequence Number: 11311834
• Product Code: FMF
• UDI-Device Identifier: 20884521015040
• UDI-Public: 20884521015040
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 8881511344
• Device Catalogue Number: 8881511344
• Device Lot Number: 912222X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1