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

Model Number 8881513207

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 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.

Manufacturer Narrative

E1 initial reporter name and address the facility and address has been corrected.

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
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 11849355
• MDR Text Key: 251442878
• Report Number: 9612030-2021-02910
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521012110
• UDI-Public: 10884521012110
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881513207
• Device Catalogue Number: 8881513207
• Device Lot Number: 2015412264
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/17/2021
• Patient Sequence Number: 1