MAUDE Adverse Event Report: COVIDIEN 60ML SYRINGE LUER LOCK TIP; SYRINGE, PISTON

Model Number 1186000777

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that during testing, when attempting to forcefully break the luer lock connection they were not successful.The device luer lock was too short and bent when attempting to remove the closed system transfer device.

Manufacturer Narrative

Please disregard the report #(b)(4).After further review of the complaint details, it was determined that this report was submitted in error, as this issue was already submitted under the report # 1915484-2019-01113.

• Brand Name: 60ML SYRINGE LUER LOCK TIP
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 9577851
• MDR Text Key: 174620402
• Report Number: 1915484-2020-01119
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521010864
• UDI-Public: 10884521010864
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1186000777
• Device Catalogue Number: 1186000777
• Device Lot Number: 929811X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2019
• Patient Sequence Number: 1