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

Model Number	8881570121
Medical Device Problem Codes	Backflow (1064); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
The customer reported that when using this flush to prime an iv pigtail catheter prior to inserting an iv, the syringe sucks the saline back into the syringe and when the syringe is used for flushing, the air is squirted out of the syringe and as soon as they let go of the plunger, air comes back into the syringe.The issues were discovered before patient use.
Additional Manufacturer Narrative
Section d4 has been updated to include lot number 20l2434.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Additional 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 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 video was provided for review which confirmed the plunger issue however the fluid leakage and label positioned was not evident in the video.Syringes for lot # 20h1424 & 20l2434 were returned to the manufacturing site for evaluation.A verification for the plunger issued was completed on the syringes; the reported phenomenon for the plunger receding is confirmed.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).A formal corrective/preventative action is in progress to address the plunger issue.

• 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: 11802312
• Report Number: 1282497-2021-10165
• Device Sequence Number: 14420239
• Product Code: NGT
• UDI-Device Identifier: 10884521000261
• UDI-Public: 10884521000261
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2021

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: 20L2434
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 04/27/2021; 04/27/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 05/14/2021; 09/14/2021
• Patient Sequence Number: 1