MAUDE Adverse Event Report: COVIDIEN 6ML SYRINGE LUER LOCK TIP NS; SYRINGE, PISTON

Model Number	8881106010
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2020
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 tip of the luer was broken and detached from the syringe.
Additional Manufacturer Narrative
The manufacturing site was provided representative photographs in relation to this customer report.In the first photograph provided, a shipper label is present identifying the related product to be product code 8881106010, lot number 928774x.In the second photograph provided, unit cartons can be observed for product code 8881106010.In the third photograph provided, a tray with seven (7) syringes can be observed containing broken plastic pieces from what appears to be the syringes present; broken luer, plunger rod, etc.The manufacturing site received two (2) cases with 100 pieces each (200 total) in relation to this customer report.A complete investigation was performed.Visual inspection to the quality inspection standard was conducted.No defect related to this complaint was observed.The device history record (dhr) for lot 928774x was reviewed which indicates that product and specification requirements were met with no non-conforming product identified relating to this customer report.No defects were confirmed with this customer report.Therefore, no certain root cause can be determined at this time.Although the defect cannot be certainly confirmed per the current investigation, a quality alert was issued and posted at the relevant process to heighten awareness of the potential condition.Per the site¿s procedure, complaint trends are evaluated monthly to determine if a corrective and preventative action (capa) is warranted.At this time, there is not enough information and a capa will not be initiated.This complaint will be used for qa tracking and trending.

• Brand Name: 6ML SYRINGE LUER LOCK TIP NS
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 10078810
• Report Number: 1915484-2020-01168
• Device Sequence Number: 19814348
• Product Code: FMF
• UDI-Device Identifier: 10884521013889
• UDI-Public: 10884521013889
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2020

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: 8881106010
• Device Catalogue Number: 8881106010
• Device Lot Number: 928774X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Initial Date Received by Manufacturer: 05/06/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 05/21/2020
• Supplement Report FDA Received Date: 07/09/2020
• Patient Sequence Number: 1