MAUDE Adverse Event Report: COVIDIEN 12ML LLK SMOOTH TIP BULK NS; SYRINGE, PISTON

Model Number 8881112599

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2019

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that 2 of the syringes had floating particles inside.One had a screw inside and one had a piece of cardboard inside.

Manufacturer Narrative

A review of the device history (dhr) record was completed.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Two (2) syringes were received for evaluation.The reported condition was observed, with one syringe containing a piece of cardboard, and one syringe containing a sheared screw both inside the barrel and inside the fluid path.The sample was not in its original packaging and showed evidence of further processing outside of cardinal health control.There was fluid in the barrel and a tip capping off the syringe.How the customer handles, fills and caps the syringe is unknown.During sample evaluation, no other damage to the syringe was observed.The method of root cause analysis implemented in this investigation was to conduct a six m assessment that evaluated potential causes.Cardboard pm: the origin of the cardboard particle is most likely from the cleaning of the tip tumbler.During regular cleaning wipes/tissues are used, it has been observed in the past that cardboard from the wipe/tissue box transports to the tip tumbler.A review of the procedure found that the instructions may be inadequate and will be updated to include instructions to verify that the tip tumbler is free of any debris.Screw pm: the origin of the screw particle is not known.Work was performed on the equipment and it may be possible that the screw originated from this repair; however, this was not confirmed.Under normal conditions this particle would have been detected during tip detection as the plunger would not have been fully exercised; however, shift notes during production reported issues with the reject cylinder.Furthermore, the pm should have been detected by the metal detector.The metal detector is challenged at the beginning and end of every lot, the dhr confirmed that the challenge test was performed.During the sample analysis the sample was confirmed to not pass the metal detector.It is possible that during production the metal detector alarmed but the issue was not addressed.Based on the information available and the investigation findings; (1) a document update to the standard work for cleaning the tip tumbler was initiated and (2) a maintenance work order was completed to fix the assembly machine reject station following completion of the reported lot.

• Brand Name: 12ML LLK SMOOTH TIP BULK NS
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 9446996
• MDR Text Key: 170136111
• Report Number: 1424643-2019-00557
• Device Sequence Number: 1
• Product Code: FMF
• 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: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881112599
• Device Catalogue Number: 8881112599
• Device Lot Number: 18L10163X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Date Manufacturer Received: 11/12/2019
• Patient Sequence Number: 1