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

Model Number	1180600777
Medical Device Problem Code	Filling Problem (1233)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the phlebotomists are complaining that the monoject 6ml syringes are giving a small initial return, but then pulling air while the needle is still inside the vein.It seems the syringe may have a gap at the rubber stopper that is pulling air in when the plunger is pulled back.There was no patient harm.
Additional Manufacturer Narrative
Additional information: h6 health effect- clinical code and impact code added.Medical device problem code, type of investigation, investigation findings, and investigation conclusions added.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.

• Brand Name: 6ML SYRINGE LUER LOCK TIP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 11417487
• Report Number: 1915484-2021-01216
• Device Sequence Number: 3876974
• Product Code: FMF
• UDI-Device Identifier: 10884521013582
• UDI-Public: 10884521013582
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 03/04/2021

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: 1180600777
• Device Catalogue Number: 1180600777
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 03/04/2021
• Patient Sequence Number: 1