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

Model Number	8881570121
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: when you flush the air out, the syringe pulls back and draws in a small amount of air again.
Additional Manufacturer Narrative
This refers to product 8881570121 0.9% sodium chloride flush syringe, 12 ml syringe with 10 ml fill with the lot number 20b0214; all manufacturing records were reviewed and nothing out of the ordinary has occurred.The investigation demonstrated that no related issue was recorded throughout all our manufacturing and control processes.The manufacturing records, including autoclave documents, were reviewed and no possible related event occurred during the overall process for this lot.A review specifically for the plunger and syringe defects was also performed and in the manufacturing records and nothing out of the ordinary has occurred.Also, each lot is released based on an acceptable quality levels (aql) sampling.As per the final quality inspection report of this lot, all specification criteria were conforming.The product was in conformance to the specifications and was released for distribution meeting all established quality assurance acceptance levels.Following previous similar complaints, a supplier corrective action report (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 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.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 the bulge in the syringe near the 10 ml mark.The bulge is found to be inherent to the sterilization process and therefore, it is not considered a deficiency.The reported condition could not be confirmed without a device analysis.The root cause of the phenomenon reported in the complaint is due to the process.

• 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: 10207161
• Report Number: 1282497-2020-09172
• Device Sequence Number: 16797734
• Product Code: NGT
• UDI-Device Identifier: 10884521000261
• UDI-Public: 10884521000261
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,user fac
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2020

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: 8881570121
• Device Catalogue Number: 8881570121
• Device Lot Number: 20B0214
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1