MAUDE Adverse Event Report: COVIDIEN 12CC SALINE SYRINGE (10CC); SALINE, VASCULAR ACCESS FLUSH

Model Number 8881570121

Device Problem Infusion or Flow Problem (2964)

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 when attempting to prime tubing with the flush, if they do not hold the plunger or clamp the tubing it backs up with air.

Manufacturer Narrative

The investigation found that there were no related issues recorded throughout the manufacturing and control processes.The manufacturing records, including autoclave documents, were reviewed and no related event occurred during the overall process for this lot.Also, each lot is released based on an acceptable quality limit (aql) inspection.The product was in conformance to specifications and was released for distribution meeting all established quality assurance acceptance levels.The syringe from this lot was procured from a supplier.The supplier has reviewed the raw material, process/method, laboratory reports, equipment/instruments and training records and didn't find any activity out of the specifications.Two unopened syringes were returned to the manufacturing site for evaluation.The two syringes were opened, and the air was pushed outside the syringe before letting go of the plunger.The plunger then receded back into the barrel letting in a little bit of air inside the luer and the shoulder of the syringe, confirming the observed phenomenon as reported.A video was also submitted with the complaint showing the issue from the syringe for another lot.The reported phenomenon is observed in the video.Following previous similar complaints, a supplier corrective action request (scar) was sent to the supplier of the syringes.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 above the 10ml mark 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.The bulge is found to be inherent to our sterilization process and therefore, it is not considered a defect.The root cause of the phenomenon reported in the complaint is due to our process that are within the aql.

• Brand Name: 12CC SALINE SYRINGE (10CC)
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10448242
• MDR Text Key: 204197875
• Report Number: 1282497-2020-09375
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 10884521000261
• UDI-Public: 10884521000261
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

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
• Device Operator: No Information
• Device Model Number: 8881570121
• Device Catalogue Number: 8881570121
• Device Lot Number: 20E0974
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 08/25/2020
• Supplement Dates Manufacturer Received: 08/18/2020
• Supplement Dates FDA Received: 11/04/2020
• Patient Sequence Number: 1