MAUDE Adverse Event Report: COVIDIEN INS SAF SYR 1CC 29X1/2IN; SAFETY NEEDLE AND SYRINGE

Model Number 8881511110

Device Problem Shielding Failure (1568)

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: 12/22/15.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a safety needle/syringe combination.The customer reports that the safety shield did not function properly.

Manufacturer Narrative

Submit date: 02/16/2016.A device history record (dhr) review of the reported lot number(s) confirmed that the product was produced accomplishing quality requirements and released according to established procedures.During the packaging of this lot, (b)(4) pieces were visually inspected and (b)(4) pieces were physically tested with 0 defects recorded relating to this customer report.There were no samples received for evaluation.Since the reported condition could not be confirmed, a root cause analysis could not be conducted and potential root causes are strictly hypothetical in nature.Possible root causes associated with a safety shield defect might include damage to the shield or collar locking and stop features, malformation of the collar or shield or excessive torque to force the shield out of the locked position.During the assembly of this product, inspectors routinely test samples for shield retract force, shield extend force, shield-locking torque, shield/collar spin force, shield detach and shield compression force.The test results are reviewed for each shop order prior to release to verify that all testing during production was acceptable and within specification limits.The product cannot be accepted unless the acceptable quality level has been met.The plastic shield on the safety syringe is designed to slide forward to cover the needle to prevent needle sticks after use.The safety mechanisms will deactivate if you do not pull the shield all the way up and twist it.The instructions for use of the safety syringe are on the back of each unit box which state: immediately following injection, extend shield forward fully until click is heard.Then lock safety shield by twisting in either direction until you feel the positive stop and hear the audible snap.Based on the existing controls and the device history record indicating the sampling and product specification requirements were met; additional correction and / or containment activities of product are not required at this time.Based on the information available and the investigation findings, a corrective and preventative action (capa) is not deemed necessary at this time.

• Brand Name: INS SAF SYR 1CC 29X1/2IN
• Type of Device: SAFETY NEEDLE AND SYRINGE
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd.; norfolk NE 68701
• Manufacturer (Section G): COVIDIEN; 1222 sherwood road; norfolk NE 68701
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5320522
• MDR Text Key: 34918970
• Report Number: 1915484-2015-00041
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8881511110
• Device Catalogue Number: 8881511110
• Device Lot Number: 510432X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1