MAUDE Adverse Event Report: COVIDIEN 3ML SYRINGE 22G X 1; SYRINGE, PISTON

Model Number 1180322100

Device Problems Fluid/Blood Leak (1250); Nonstandard Device (1420)

Patient Problem No Consequences Or Impact To Patient (2199)

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 that the human use syringe does not have a tight seal as it squirts out when end user applies pressure.Additional information received stated that the syringes are used primarily for equine but occasionally farm dog/cat, vaccines.The customer despite checking/tightening the luer lock seal, syringes leak (squirt out around luer seal) when they give an injection sometimes after.4 to.6 ml of 1ml have gone in the muscle, the rest squirts out with the needle still 1" in the muscle.Sometimes only.1 to.2 ml goes in before squirting out.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was release accomplishing all quality standards.Samples were submitted with this complaint as well as a photo but the reported issue could not be confirmed; the samples were visually and physically tested and were found to be in good standing.As the samples did not exhibit any defect this root cause could not be 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, this lot met all defined acceptance requirements and was released.The investigation did not identify a systemic issue with the product or process, no trend exists for the issue reported, and a specific root cause could not be identified based on available information.Therefore, a corrective and preventive action (capa) is not necessary at this time.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: 3ML SYRINGE 22G X 1
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 10312042
• MDR Text Key: 199989957
• Report Number: 1017768-2020-00834
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521012356
• UDI-Public: 10884521012356
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1180322100
• Device Catalogue Number: 1180322100
• Device Lot Number: 513841X
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/08/2020
• Patient Sequence Number: 1