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

Model Number 8881570121

Device Problem Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device history (dhr) record including the incoming inspection reports, laboratory records, equipment, manufacturing and personnel training records were reviewed and nothing out of the ordinary was found.Five unopened syringes were returned to the manufacturing site for evaluation.Three returned syringes were opened, and the air was pushed outside each syringe before letting go of the plunger.The plunger then receded back into the barrel letting air inside.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 related event occurred during the overall process for this lot.A review specifically for plunger and syringe issues was also performed in the manufacturing records and nothing out of the ordinary has occurred.Also, each lot is released based on an aql inspection.As per the final quality inspection report of this lot, all specification criteria were conforming.The product was in conformance to our specifications and was released for distribution meeting all established quality assurance acceptance levels.A supplier corrective action request (scar) was sent to our supplier of syringes.An examination of samples from previous complaints 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.For the current complaint, the negative push back of the plunger into the syringe is most likely due to a bulge in the syringe near the 10ml mark.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.No corrective or preventive action will be initiated for the moment.This case will used for tracking and trending purposes.

Event Description

The customer reported that they are having issues with the iv flush syringes ¿free falling¿ when positive pressure is removed resulting in the possibility of back flow or air being inadvertently instilled into the iv tubing.Additional information stated that the issues were found prior to patient use.It was also stated that the customer's issue is regarding the potential risk of air being introduced into the syringe or line; it did not actually occur.On 23-nov-2020 the supplier confirmed that during functional evaluation of the returned device, the syringes were opened, and the air was pushed outside each syringe before letting go of the plunger.The plunger then receded back into the barrel letting air inside,.

• Brand Name: 12CC SALINE SYRINGE (10CC)
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 11028930
• MDR Text Key: 226016935
• Report Number: 1282497-2020-09798
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 10884521000261
• UDI-Public: 10884521000261
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• 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: 20F1184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Date Manufacturer Received: 11/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1