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

Model Number	8881570121
Medical Device Problem Codes	Fluid/Blood Leak (1250); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the prefill syringe is not steady.The syringe is adding air in the dead space and causing potential patient issues.The customer also stated that when the plunger is pushed back, it moves slowly on it's own causing fluid to leak.
Additional Manufacturer Narrative
D4: correction originally reported as unknown lot number is now updated to lot # 20f1224.The investigation found that there were no related issues recorded throughout the manufacturing and control processes.The manufacturing records, including autoclave documents, were reviewed for the reported lot 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.A sample was not returned for evaluation however a video was available for review and the lot number was visible.As seen in the video, 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.This confirms the observed phenomenon from the complaint.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 deficiency.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)
• Common Device Name: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11205609
• Report Number: 1282497-2021-09858
• Device Sequence Number: 19385677
• Product Code: NGT
• UDI-Device Identifier: 10884521000261
• UDI-Public: 10884521000261
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2021

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
• Operator of Device: No Information
• Device Model Number: 8881570121
• Device Catalogue Number: 8881570121
• Device Lot Number: 20F1224
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 03/29/2021
• Patient Sequence Number: 1