MAUDE Adverse Event Report: COVIDIEN 60ML SYRINGE LUER LOCK TIP SYR; SYRINGE, PISTON

Model Number	1186000777T
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the 60ml syringe is reportedly spontaneously detaching from the 4-way stopcocks.The customer further stated that the physician had experienced difficulty attaching the syringe to the female luer of the stopcock.
Additional Manufacturer Narrative
Section d3 & g1: updated to reflect the correct manufacturing facility address.
Additional Manufacturer Narrative
A device history record of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.A photograph was submitted for evaluation and based on the digital image it was possible to confirm the reported condition; the film and lite sleeves were broken.Although a fed ex label was generated for a return of the physical sample, an actual shipment was never initiated.The potential root cause for the condition is that the material was trapped while sealing the package causing the package to rupture and subsequently resulting in a broken component.A quality alert was initiated to notify to personnel of the condition reported by the customer.A change was made to the inspection level from normal to a heightened level.These changes have been implemented.

• Brand Name: 60ML SYRINGE LUER LOCK TIP SYR
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood road; norfolk NE 68701
• MDR Report Key: 9806569
• Report Number: 1282497-2020-08958
• Device Sequence Number: 609486
• Product Code: FMF
• UDI-Device Identifier: 10884521189645
• UDI-Public: 10884521189645
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2020

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: 1186000777T
• Device Catalogue Number: 1186000777T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 02/26/2020; 02/26/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 04/23/2020; 05/11/2020
• Patient Sequence Number: 1