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

Model Number 8881570121

Device Problem Material Discolored (1170)

Patient Problem No Patient Involvement (2645)

Event Date 08/05/2019

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 they found some sort of yellow liquid inside one of the prefill flush syringe.

Manufacturer Narrative

Evaluation summary the device history record (dhr) was reviewed showing nothing out of the ordinary occurred during the overall process of the lot.No maintenance or mechanical issues occurred.A sample was received for evaluation and the reported issue was confirmed.A foreign matter was observed on the black piston of the plunger.The contamination is not microbiological and was concluded to be rust originating from a rusted particle embedded in the black piston.Therefore, the foreign matter observed on the black piston is most likely a metal particle made of iron.The syringe is filled with saline that is filtered so it is unlikely it would have been introduced during this manufacture process.It is most likely that the metal particle was already in the syringe when it was received from the syringe supplier.The sample was sent to the syringe supplier for further investigation.No corrective or preventive action is planned at this time.If additional information is received, the investigation will resume as needed.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: 8997041
• MDR Text Key: 158949171
• Report Number: 1282497-2019-08642
• 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: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• 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: 18K2224
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/05/2019
• Patient Sequence Number: 1