MAUDE Adverse Event Report: CM AMERICAS 30327 12CC SALINE SYRINGE {CAN} (10CC); PREFILL SYRINGE

Model Number 8881570121

Device Problem Filling Problem (1233)

Patient Problem No Patient Involvement (2645)

Event Date 09/04/2014

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue with a pre-fill syringe.The customer reports the prefill syringes in the box were only half full.There was no patient involvement.

Manufacturer Narrative

Submit date: 10/01/2014.An investigatin is currently underway, upon completion the results will be forwarded.

Manufacturer Narrative

One box of samples product 8881570123, lot 13h1604 was received for evaluation.Photographs of the box and the content were sent to the supplier for analysis.The supplier confirmed that the photographs and the syringes in the box correspond to the label on the box.A device history record (dhr) review was completed for lot# 13h1604 which was released on august 13, 2013.There were no manufacturing related issues related to the complaint issued for this lot.The syringes were filled at 3 ml as per the labels and as per the manufacturing records of lot 13h1604.The product was packaged properly.A root cause analysis determined the most likely root causes to be either the customer expected 10 ml syringes or that there was a mistake when ordering or the wrong product was shipped to the customer.There is no corrective or preventive action planned at this time as this product was manufactured and packaged properly at the supplier.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: PREFILL SYRINGE
• Manufacturer (Section D): CM AMERICAS; 7500 trans canada hwy.; pointe claire; quebec H9R 5 H8; CA H9R 5H8
• Manufacturer (Section G): MALLINCKRODT; 7500 trans canada hwy.; pointe claire; quebec H9R 5H8; CA H9R 5H8
• Manufacturer Contact: elaine bishop ; 15 hampshire street; mansfield, MA 02048 ; 5084524686
• MDR Report Key: 4131530
• MDR Text Key: 4938736
• Report Number: 1282497-2014-00048
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2014

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: Other
• Device Model Number: 8881570121
• Device Catalogue Number: 8881570121
• Device Lot Number: 13H1604
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2014
• Initial Date FDA Received: 10/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1