MAUDE Adverse Event Report: COVIDIEN 12CC SALINE SYRINGE (5CC).; SALINE, VASCULAR ACCESS FLUSH

Model Number 8881570125

Device Problem Backflow (1064)

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

Event Date 03/30/2021

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 the registered nurse prepares the saline lock to start the iv, they attach the flush to lock and flush with saline, then the saline empties back in the flush.Additional information received on 21-apr-2021 stated that when the saline all goes back into the syringe it does not appear that air enters the syringe, but the catheter extension set is left with only air, no fluid.

Manufacturer Narrative

The investigation found that there were no related issues recorded throughout the manufacturing and control processes.The manufacturing records 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.The product was in conformance to our specifications and was released for distribution meeting all established quality assurance acceptance levels.A supplier corrective action report (scar) was sent to our supplier of the prefill syringes.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 is most likely due to a bulge in the syringe near the 5ml mark of the syringe.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 where the rubber tip resides.Depending on the actual dimensions of the rubber tip, barrel internal diameter and autoclave processing, the extent of the bulge may vary.The bulge is found to be inherent to our sterilization process and therefore, it is not considered a defect.No samples or video/pictures were provided by the customer.The root cause of the phenomenon reported in the complaint is due to our process.No corrective or preventive action will be initiated at this time.

• Brand Name: 12CC SALINE SYRINGE (5CC).
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11712294
• MDR Text Key: 246985181
• Report Number: 1282497-2021-10094
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30884521005567
• UDI-Public: 30884521005567
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881570125
• Device Catalogue Number: 8881570125
• Device Lot Number: 2060684
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/05/2021
• Patient Sequence Number: 1