MAUDE Adverse Event Report: COVIDIEN 20ML SYR LUER LOCK TIP RP; SYRINGE, PISTON

Model Number 8881520657

Device Problems Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2021

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 reported that the tip of the luer lock is missing and threads are bent.The syringe was found by the nurse when they went to try and fill with normal saline.The syringe never made it to patient.The issue caused more work for the nurse.There was no clinical significance nor injury to patient or staff.

Manufacturer Narrative

Investigation summary: the manufacturing site was provided three (3) representative photographs for evaluation.In each photograph, the reported issue of damaged luer and missing syringe tip can be observed.It is unknown whether each photograph is one single syringe in different angles or if each photograph is a unique representative sample.One unpackaged sample was also received for evaluation.A complete investigation was performed.Visual inspection to the quality inspection standard was conducted.The luer tip was broken off at the base of the barrel face and the luer skirt was damaged/non-functional.A low top line was also identified along with barrel printing not aligned with the flat of the barrel flange.The device history record (dhr) for lot 024440x was reviewed.This product was manufactured and packaged on july 23-24, 2020.During the manufacturing of the syringe assemblies, syringes were visually inspected and physically tested with no failures recorded relating to this reported issue.The molded syringe barrel inspection reports were reviewed with no failures recorded relating to this reported issue.The dhr for the lot control indicates that product and specification requirements were met with no non-conforming product identified relating to this reported issue.Based on all available information, the reported condition cannot be confirmed to be manufacturing-related and the exact root cause could not be determined.However as part of continuous improvements, a requirement to perform verification of missing tip failures sensors at the printer station and verification of barrel eject sensors after each blowoff each shift of production was implemented october 2020.Per procedure, complaint trends are evaluated during the monthly corrective and preventive action (capa) meeting to determine if a capa is warranted.At this time, no trend exists and there is not enough information therefore a capa will not be initiated.The reported complaint will be communicated to the appropriate manufacturing and quality assurance personnel for awareness.

• Brand Name: 20ML SYR LUER LOCK TIP RP
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 11258872
• MDR Text Key: 229667230
• Report Number: 1915484-2021-01206
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 20884521012155
• UDI-Public: 20884521012155
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8881520657
• Device Catalogue Number: 8881520657
• Device Lot Number: 02440X
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/29/2021
• Patient Sequence Number: 1