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 10/25/2019

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 tiny air bubble was created in the flush when inserted into an injection cap.Additional information received from the customer stated that they noticed small air bubbles once connected to the injection cap (ultrasite).The customer further stated that the plunger was not sealing properly with the barrel.The clinician ultimately was leaving fluid in the syringe barrel so the bubbles would stay within the syringe.No patient harm reported.

Manufacturer Narrative

H 3 evaluation summary: a review of the device history record (dhr) for the received lot number showed no indication of any issues during the processing of this lot that would contribute to the reported condition.The incoming inspection reports for the syringes used in this batch showed conformance.Also, the manufacturing records were reviewed and showed no discrepancies.All tests performed on the finished product were within their limits and the equipment was in proper functioning conditions.The syringes used in the manufacturing of the finished product are received already lubricated with silicone to ensure adequate travelling of the piston.This lubrication is verified by our incoming quality control department prior to the release of the components and all lots were found conforming.Four unused syringes were returned to the manufacturing site; however, all four syringes were received damaged and it was not possible to perform further examination on the returned samples.The reported condition could not be confirmed.The exact root cause of this event could not be identified as the samples were received damaged.No corrective or preventive actions will be initiated at this time.This complaint will be used for tracking and trending purposes.

• 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: 9310622
• MDR Text Key: 166319896
• Report Number: 1282497-2019-08766
• 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
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• 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: 18F1234
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/25/2019
• Patient Sequence Number: 1