MAUDE Adverse Event Report: COVIDIEN 35ML SYR ASSY FOR DET. PLUNGER; SYRINGE

Model Number 8881135609

Device Problems Break (1069); Detachment Of Device Component (1104); Device Inoperable (1663)

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: 5/18/2016.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 syringe.The customer reports the inner luer tip of the syringe broke off.

Manufacturer Narrative

A device history record review of the reported lot number(s) confirmed that the product was produced accomplishing quality requirements and released according to established procedures.One decontaminated sample without original package or lot number was received at the manufacturing plant for evaluation.The reported issue was confirmed.After performing visual inspection per procedure, the issue was observed in the syringe broke.The syringe component is produced by external supplier and the assembly process consists in a pick and place operation.There is no additional inspection on the line to detect the condition reported.A formal investigation was open in order to determine the root cause and implement the appropriated corrective action(s); it was initiated to the supplier.The capa is currently in phase open investigation.Preventive action awareness training was performed to all personnel to ensure they are aware about this reported condition.

• Brand Name: 35ML SYR ASSY FOR DET. PLUNGER
• Type of Device: SYRINGE
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; calle 9 sur 1113; cd industrial; tijuana ; MX
• Manufacturer Contact: thom mcnamara ; 15 hampshire st; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5663970
• MDR Text Key: 46288233
• Report Number: 9612030-2016-00229
• Device Sequence Number: 1
• Product Code: FMF
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8881135609
• Device Catalogue Number: 8881135609
• Device Lot Number: 525781164X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1