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

Model Number	8881512878
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2020
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 the syringe is missing the luer lock part.There was no patient harm.
Additional Manufacturer Narrative
The device history record review concluded no abnormal process conditions were present during the manufacturing of this product that would lead to the reported condition.The sample analysis confirmed the reported condition; the luer component is broken off.The root cause investigation concluded the most probable cause of the issue may have occurred during the molding process.The damage is consistent with damage that has previously been observed during the molding process.A review of the lot, shift notes, preventative maintenance, work orders and shift notes did not find any evidence that there were any issues during the manufacturing of the reported lot, therefore at this time it¿s not conclusive that issues in the molding process caused the observed condition but it cannot be ruled out as the significant factor.Based on the information available and the investigation findings, additional actions are deemed unnecessary at this time.If additional information is received warranting further analysis, the investigation will be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: 12ML SYRINGE LUER LOCK TIP RP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 10935898
• Report Number: 1424643-2020-00586
• Device Sequence Number: 19907441
• Product Code: FMF
• UDI-Device Identifier: 20884521012094
• UDI-Public: 20884521012094
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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: 04/26/2025
• Device Model Number: 8881512878
• Device Catalogue Number: 8881512878
• Device Lot Number: 20D22563X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 05/19/2021
• Patient Sequence Number: 1