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

Model Number	1181200777
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
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 reported they have found contamination in and on the syringes.It appears to be black or green mold like and is found in the stock on a variety of floors.Additional information received stated the contamination is both inside and outside the syringe in the fluid path.
Additional Manufacturer Narrative
H3 evaluation summary: the device history record (dhr) review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.A sample was received at the manufacturing facility for evaluation.A brownish sticky substance can be observed smeared on the plunger.The substance is consistent with the type of grease used on the manufacturing equipment.The root cause of the reported issue was determined to be insufficient cleaning.The substance observed on the sample was determined to be grease used on the assembly equipment.A review of maintenance records identified a work order was performed during the production of this lot on the conveyer belt.Additionally, during an informal interview with quality personal it was noted that they remember observing grease on the conveyor belt roughly around the time of production and they immediately cleaned the area.At the time of the incident the quality personal did not believe that product was impacted.A corrective and preventative action (capa) is deemed not necessary based on the reported condition¿s risk to patient/user and trending.The issue will be monitored through routine complaint trend analysis and reviewed by the capa review board (crb) for capa as necessary.This complaint will be used for tracking and trending purposes.

• Brand Name: 12ML SYRINGE LUER LOCK TIP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 11848575
• Report Number: 1424643-2021-00601
• Device Sequence Number: 3746992
• Product Code: FMF
• UDI-Device Identifier: 10884521010000
• UDI-Public: 10884521010000
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 06/25/2021

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 Expiration Date: 02/04/2026
• Device Model Number: 1181200777
• Device Catalogue Number: 1181200777
• Device Lot Number: 21B06663X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/25/2021
• Patient Sequence Number: 1