MAUDE Adverse Event Report: COVIDIEN 1ML BBL SHORT REG WOS UPT 3622; SYRINGE, PISTON

Model Number 5551771010

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that there was excess plastic/flash on the luer nibs causing fitting issues when the tubes are fitted into fixtures.The excess comes away during application.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Twenty-one barrels were received at the manufacturing site for evaluation.A complete investigation was performed.Visual inspection to the quality inspection standard was conducted.Flash was identified on the syringe tips of all syringe barrels received.The syringe barrels were submitted to the metrology lab to measure the flash to assess whether the flash was within specification.There were 0 issues confirmed per the qis.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• Brand Name: 1ML BBL SHORT REG WOS UPT 3622
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 10392887
• MDR Text Key: 202442683
• Report Number: 1915484-2020-01180
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5551771010
• Device Catalogue Number: 5551771010
• Device Lot Number: 015335X
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/20/2020
• Patient Sequence Number: 1