MAUDE Adverse Event Report: COVIDIEN PREVENT 3ML COMBO 23 X 1; SYRINGE, PISTON

Model Number	26547
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 luer tip of the device was detached inside the package.
Additional Manufacturer Narrative
The device history record (dhr) for the reported lot indicates no issues were found in visual and physical samples inspected.There were no nonconformance reports (ncr) related to this lot.There were no samples submitted with this complaint, however, a picture was sent by the customer and was analyzed.The needle hub looked to be fractured into 2 pieces.The reported condition is confirmed based on the customer provided image.The exact root cause of the reported condition could not be determined without a physical sample to examine.There was no indication of a systemic issue with the process or production.Based on available information, no corrective actions are required at this time.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: PREVENT 3ML COMBO 23 X 1
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 9608625
• Report Number: 1017768-2020-00776
• Device Sequence Number: 10899567
• Product Code: FMF
• UDI-Device Identifier: 10612479201054
• UDI-Public: 10612479201054
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2020

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: 26547
• Device Catalogue Number: 26547
• Device Lot Number: 920367
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 01/20/2020
• Supplement Report FDA Received Date: 03/25/2020
• Patient Sequence Number: 1