MAUDE Adverse Event Report: COVIDIEN 12ML SALINE SYRINGE (3ML); SALINE, VASCULAR ACCESS FLUSH

Model Number 8881570123

Device Problem Air/Gas in Device (4062)

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 when they expel the air at the tip of the syringe and let go of the plunger, the plunger retracts and pulls air back into the syringe.

Manufacturer Narrative

The device history record for the reported lot number was reviewed.The incoming inspection reports for the syringes used in this batch showed that they were in conformance and were released accordingly.The manufacturing records including laboratory test reports, equipment/instruments and personnel involved in the manufacturing of this lot and found nothing out of the specification.Ninety unopened syringes were returned.Five syringes were tested: when the air is pushed outside the syringe and after letting go of the plunger, the plunger then recedes back into the barrel letting air inside.A review specifically for plunger and syringe failures was performed in the manufacturing records and nothing out of the ordinary has occurred.Furthermore, each lot is released based on an aql inspection.As per the final quality inspection report of the reported lot, all specification criteria were conforming.The product was in conformance to the supplier¿s specifications and was released for distribution meeting all established quality assurance acceptance levels.A notification was sent to the supplier of syringes.Previous examination of 10/12ml samples showed a slight bulge on the syringe just above the 10ml mark of the label.A bulge is a slight deformation of the barrel, a variation of the diameter on the barrel length.The negative push back of the plunger into the syringe upon opening is most likely due to a bulge in the syringe near the 3ml mark of the syringe.The rubber tip is designed with a larger outside diameter than the syringe barrel internal diameter.This design is intentional and prevents any leakage during use while providing a good seal to maintain sterility of the finished product.This design causes the rubber tip to put pressure on the barrel walls.When the syringe goes through the autoclave process, heat is created which likely causes the syringe barrel wall to form over the rubber tip creating this bulge where the rubber tip resides.Depending on the actual dimensions of the rubber tip, barrel internal diameter and autoclave processing, the extent of bulge may vary.Per the supplier, the bulge is found to be inherent to the sterilization process and therefore, it is not considered a failure.However, we have initiated a corrective and preventive action internally which is in progress.Further actions will be decided based on the root cause investigations.This complaint will be used for tracking and trending purposes.

• Brand Name: 12ML SALINE SYRINGE (3ML)
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11436277
• MDR Text Key: 239106942
• Report Number: 1282497-2021-09953
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30884521005550
• UDI-Public: 30884521005550
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/26/2021

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
• Device Operator: No Information
• Device Model Number: 8881570123
• Device Catalogue Number: 8881570123
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/08/2021
• Supplement Dates Manufacturer Received: 03/03/2021
• Supplement Dates FDA Received: 05/26/2021
• Patient Sequence Number: 1