MAUDE Adverse Event Report: COVIDIEN 12ML LUER LOCK TIP PHARM TRAY; SYRINGE, PISTON

Model Number	8881516200
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reports fibers and particulate matter found in 3 syringes and 4 trays.
Additional Manufacturer Narrative
Correction: model number and catalog number has been corrected from 8881512258 to 8881516200.Unique identifier # has been corrected from (b)(4) to (b)(4).Additional information: after reviewing the database and the device history record (dhr), the lot number reported by the customer does not correspond to the product code reported.However, the lot corresponds to another part number for the monoject syringe pharmacy trays family.The dhr review was performed for the product code that corresponds with the reported lot number.The dhr file indicates that product was released meeting all quality standard requirements.There were no samples submitted with this complaint.The complaint will be reopened if a sample is received.A formal investigation was done by the multidisciplinary team.It was determined that the probable root cause is related to maintenance activities, relating to equipment cleaning, and exposed conveyors creating an opportunity.A definite root cause was unable to be determine cause a corrective and preventative action (capa) was opened to address this issue.A quality alert was generated to document the loose contamination failure mode and preventive maintenance was executed on the line.Protective guards were installed on the conveyor at material entry and exit.An ionized air tube was installed, and the syringe feeder was replaced.The acrylic in the doors and the conveyor band was replaced, the tooling cars were relocated, and autonomous maintenance was implemented on the line.

• Brand Name: 12ML LUER LOCK TIP PHARM TRAY
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 8768396
• Report Number: 9612030-2019-02212
• Device Sequence Number: 1707725
• Product Code: FMF
• UDI-Device Identifier: 10884521010970
• UDI-Public: 10884521010970
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2019

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
• Operator of Device: No Information
• Device Model Number: 8881516200
• Device Catalogue Number: 8881516200
• Device Lot Number: 1901532564
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 07/08/2019
• Supplement Report FDA Received Date: 10/03/2019
• Patient Sequence Number: 1