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

Model Number 1186000777

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

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

The customer reports that during preparation, the syringe tip was intact when removed from the wrapper, the compounding technician successfully attached the phaseal luer lock injector onto the syringe, but when the technician attached the phaseal luer lock injector to the phaseal ¿y¿ infusion adapter, the syringe tip broke off.This resulted in chemo spills inside the vertical flow hood.

• Brand Name: 60ML SYRINGE LUER LOCK TIP
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• Manufacturer (Section G): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 9936368
• MDR Text Key: 187520381
• Report Number: 1915484-2020-01149
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521010864
• UDI-Public: 10884521010864
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• 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: 935736X
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/12/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1