MAUDE Adverse Event Report: COVIDIEN PREVENT 3ML COMBO 25 X 1; SYRINGE, PISTON

Model Number 26548

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2019

Event Type  malfunction  

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 Description

Customer reports: needle is extremely loose and not attached to the syringe.Per additional information received on 06/03/19,: the entire unit became unscrewed from the syringe.

• Brand Name: PREVENT 3ML COMBO 25 X 1
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• Manufacturer (Section G): COVIDIEN; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 8678681
• MDR Text Key: 147338605
• Report Number: 1017768-2019-00650
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10612479201085
• UDI-Public: 10612479201085
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 26548
• Device Catalogue Number: 26548
• Device Lot Number: 822720
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1