MAUDE Adverse Event Report: COVIDIEN 30327 12CC SALINE SYRINGE {CAN} (10CC)

Model Number 8881570121

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/23/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 03/01/2016.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a saline syringe.The customer states they noticed something growing within the syringe.

Manufacturer Narrative

Device history record (dhr) review was completed for lot 16a0024 manufactured in january of 2016.There were no manufacturing related issues related to the complaint reported for this lot.One unopened, unused syringe was returned from the customer and forwarded to the supplier for investigation.On the shoulder of the syringes, inside the syringe, there is a round foreign matter; black in the middle and orange on the side.There are also orange particles moving in the solution.The embedded matter was identified as a piece of metal and not microbial in nature.This complaint will be considered confirmed.The syringe arrives at the manufacturing facility in one piece and is never opened prior to the filling process.It was identified that the embedded matter might have come from the syringe supplier.A root cause determined the matter coming from the manufacturing process of the syringe supplier.The manufacturing location has taken corrective action in issuing a supplier corrective action to the syringe supplier for further investigation.Additional investigation is being conducted.If additional information is received, the investigation will resume as needed.This complaint will be used for trending purposes.

• Brand Name: 30327 12CC SALINE SYRINGE {CAN} (10CC)
• Type of Device: SALINE SYRINGE
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire st.; mansfield MA 02048
• Manufacturer Contact: thom mcnamara ; 15 hampshire st.; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5471569
• MDR Text Key: 39669834
• Report Number: 1282497-2016-00037
• Device Sequence Number: 1
• Product Code: NGT
• 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,Followup
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8881570121
• Device Catalogue Number: 8881570121
• Device Lot Number: 16A0024
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1