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

Model Number 8881570121

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2020

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 they attach the prefill syringe to the iv tubing and insert the syringe on to flush, some air into the line was noticed due to negative pressure push back.There was no harm to the patient involved.

Manufacturer Narrative

H 3 evaluation summary the device history record (dhr) was reviewed and nothing out of the ordinary has occurred during the process.A review of the incoming inspection reports for the syringes used in this batch showed that they were in conformance and were released accordingly.The equipment used was in proper functioning condition during the manufacturing, filling and packaging of this lot.One unopened syringe was returned to the manufacturing site for evaluation.The syringe was opened, and the air was pushed outside the syringe before letting go of the plunger.The plunger then receded back into the barrel letting air inside, confirming the observed phenomenon.The investigation demonstrated that no related issue was recorded throughout all the 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 plunger and syringe defects was also performed and in the manufacturing records, nothing out of the ordinary had occurred.Also, each lot is released based on a quality sampling.As per the final quality inspection report of this lot, all specification criteria were conforming and was released for distribution meeting all established quality assurance acceptance levels.The returned sample was sent to the supplier of the syringes.The examination showed a slight bulge on the syringe just above the 10 ml mark of the label.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 defect.The root cause of the phenomenon reported in the complaint is due to the process.No corrective or preventive action will be initiated at this time.This complaint will be used for tracking and trending purposes.

Manufacturer Narrative

H 3: evaluation summary: the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all dhrs are reviewed and approved by quality, prior to release of product.The equipment used was in proper functioning condition during the manufacturing, filling, and packaging of this lot.One unopened syringe was returned for the evaluation.The syringe was opened, and the air was pushed outside the syringe before letting go of the plunger.The plunger then receded back into the barrel letting air inside.Therefore, the issue reported by the customer is observed.The investigation demonstrated that, no issues were recorded throughout the 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 was performed specifically for the plunger and syringe issues in the manufacturing records and no issues were found.Also, each lot is released based on an acceptable quality limits (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 the established quality assurance acceptance levels.The returned sample was sent to the supplier of the syringes for the analysis.The examination showed a slight bulge on the syringe just above the 10 ml mark of the label.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 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 the sterilization process and therefore, it is not considered as an issue.The root cause of the reported incident is due to the supplier¿s process.A formal investigation is not deemed necessary at this time.

• 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: 9687410
• MDR Text Key: 179379903
• Report Number: 1282497-2020-08911
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2020

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: 19I1144
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/05/2020
• Initial Date FDA Received: 02/10/2020
• Supplement Dates Manufacturer Received: 02/05/2020; 02/05/2020
• Supplement Dates FDA Received: 06/01/2020; 07/07/2020
• Patient Sequence Number: 1