MAUDE Adverse Event Report: COVIDIEN 3ML LUER LOCK PHARMACY TRAY; SYRINGE, PISTON

Model Number	8881513207
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 the plunger is too hard to pull and push when preparing vaccines.It is difficult to adjust during both injection and while drawing up.
Additional Manufacturer Narrative
E1 initial reporter name and address the facility and address has been corrected.
Additional Manufacturer Narrative
The device history record (dhr) file was reviewed indicating that product was released meeting all quality standard requirements.Five decontaminated monojec 3 ml syringes outside of its original package and without a lot number was received for evaluation.The component is produced by an external supplier and the assembly process at this plant consists of a pick and place operation.There is no additional inspection on the line that would detect the reported condition before placement into the package.The root cause confirmation will be provided by the manufacturer (supplier) and will be documented through the supplier corrective action request (scar) notification and response form.

• Brand Name: 3ML LUER LOCK PHARMACY TRAY
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 11849355
• Report Number: 9612030-2021-02910
• Device Sequence Number: 3746995
• Product Code: FMF
• UDI-Device Identifier: 10884521012110
• UDI-Public: 10884521012110
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2021

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: 8881513207
• Device Catalogue Number: 8881513207
• Device Lot Number: 2015412264
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 05/17/2021; 05/17/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 05/19/2021; 09/01/2021
• Patient Sequence Number: 1