MAUDE Adverse Event Report: COVIDIEN 3ML SYRINGE LUER LOCK TIP RP; SYRINGE, PISTON

Model Number	8881513934
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/22/2019
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.
Event or Problem Description
The customer reported that when the medication is drawn up into the syringe in the airflow hood in the pharmacy, the syringe tip begins leaking after the cap is put on.The method that is used to cap is pressure against the hoods counter.The syringes are all filled to 2 1/2 ml before capping.There were no patients involved.
Additional Manufacturer Narrative
Section b5 was updated to include the following statement: "the leak occurred at the plunger end of the syringe." 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 the release of product.Sixty-five decontaminated samples were received at the manufacturing site for the investigation.Visual and functional evaluations were performed, and the reported condition could not be confirmed; the syringes all met specification and passed leak testing.A root cause could not be determined as the reported issue was not confirmed.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.Specifically, samples are inspected for plunger actuation.The lot met the acceptance criteria and was released.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes to determine the need for corrective actions.
Event or Problem Description
The customer reported that when the medication is drawn up into the syringe in the airflow hood in the pharmacy, the syringe tip begins leaking after the cap is put on.The method that is used to cap is pressure against the hoods counter.The syringes are all filled to 2 1/2 ml before capping.The leak occurred at the plunger end of the syringe.There were no patients involved.

• Brand Name: 3ML SYRINGE LUER LOCK TIP RP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 9265733
• Report Number: 1017768-2019-00718
• Device Sequence Number: 2497994
• Product Code: FMF
• UDI-Device Identifier: 20884521012858
• UDI-Public: 20884521012858
• 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
• Report Date (Section B): 03/03/2020

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: 8881513934
• Device Catalogue Number: 8881513934
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 03/03/2020
• Patient Sequence Number: 1