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)
Date of Event	05/13/2021
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
Initial reporter name and address was corrected.
Additional Manufacturer Narrative
Added h6 evaluation codes: component code; type of investigation; investigation findings; investigation conclusions.Investigation summary: a device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality prior to release of product.No physical samples or digital images provided.A web address to an external video hosting site was provided.Per the video, a syringe with liquid is observed and the plunger is pushed.It cannot be determined through the video if the sample presents the problem reported.The complaint shall be reopened if a sample is received at a later date.The manufacturing process was reviewed with the multifunctional team.All process and controls were found properly followed, including sub-assemblies, finished product assembly, packaging and inspections performed to the product.There were no abnormal conditions found that could trigger the reported condition; as well, there have been no similar cases detected in our manufacturing process for this failure mode in the past.Based on the available information, no action plan is deemed required at this time.The current process is running according to product specifications meeting quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.

• 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: 11849164
• Report Number: 9612030-2021-02909
• Device Sequence Number: 3746994
• 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): 08/25/2021

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 05/13/2021; 05/13/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 05/19/2021; 08/25/2021
• Patient Sequence Number: 1