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

Model Number	1186000777
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that the luer tip breaks off during manipulation during compounding and the luer lock tip is flexing when used with a closed system transfer device.
Additional Manufacturer Narrative
H 3 : evaluation summary the device history record (dhr) for the reported lot was reviewed.This product was visually and physically tested with no issues recorded relating to this customer report.The product and specification requirements were met with no non-conforming product identified.The manufacturing site received one unsealed packaged sample for evaluation.A visual inspection was conducted showing the luer tip was broken off at the base of the barrel face and the majority of the luer skirt was broken off, most likely from a twisting motion.The reported condition of broken luer tip is confirmed for the one syringe sample provided.Although the exact root cause cannot be determined, some likely root causes can be due to damage incurred during transport in the air glide tubes during assembly, or due to technique used by the end user.A quality alert will be distributed to the appropriate quality and production personnel to heighten awareness of the reported condition.Per procedure, complaint trends are evaluated during the monthly corrective and preventative action (capa) meeting to determine if a capa is warranted.This complaint will be used for tracking and trending purposes.

• Brand Name: 60ML SYRINGE LUER LOCK TIP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 9732229
• Report Number: 1915484-2020-01132
• Device Sequence Number: 14041532
• Product Code: FMF
• UDI-Device Identifier: 10884521010864
• UDI-Public: 10884521010864
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

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: 1186000777
• Device Catalogue Number: 1186000777
• Device Lot Number: 933647X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 04/29/2020
• Patient Sequence Number: 1