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

Model Number 1186000777

Device Problems Fitting Problem (2183); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that when the pharmacy opened the package of the 60 ml syringe, the luer lock tip of the syringe was half way closed and they were unable to attach a needle.There was no harm to any patients or employees with this syringe.

Manufacturer Narrative

H 3 sample evaluation: the device history record (dhr) for the reported lot was reviewed.During the packaging of this lot, pieces were visually and physically tested with no issues recorded relating to this customer report.The manufacturing site received one unpackaged sample for evaluation.A visual inspection to the quality inspection standard was conducted.A damaged luer tip was identified on the syringe sample.The luer tip was bent and the plastic material was skived, causing the opening of the tip to be non-cylindrical.The reported condition of damaged syringe tip causing occlusion of fluid path is confirmed for the one syringe sample provided.The most probable root cause is due to damage that incurred during transport during the assembly process.A quality alert will be distributed to the appropriate quality and production personnel to heighten awareness of the reported condition.Per procedure, complaint trends are evaluated during the monthly corrective and preventative action (capa) meeting to determine if a capa is warranted.This complaint will be used for tracking and trending purposes.

• 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: 9602604
• MDR Text Key: 176684822
• Report Number: 1915484-2020-01122
• 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,user f
• 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: 01/17/2020
• 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: 927708X
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/14/2020
• Patient Sequence Number: 1