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

Model Number 1182000777

Device Problem Crack (1135)

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

Event Date 04/14/2021

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 syringes crack when in use.No patient injury was reported.

Manufacturer Narrative

A device history record confirmed that the product was produced accomplishing quality requirements and released according to established procedures.The manufacturing site received one photograph and a single unsealed package syringe with this customer report.A complete investigation was performed.A visual inspection to the quality inspection standard was conducted.A vertical crack in the side of the syringe extending from just below the base of the threading within the luer to approximately the 15 ml graduation line can be observed.Crystallized debris is present inside the syringe on the surface of the rubber tip is present indicating the crack occurred during use.The identification of the substance is unknown.As a result of the current investigation, the reported condition is not determined to be a manufacturing related.Complaint trends are evaluated during a monthly meeting to determine if a formal corrective/preventative action (capa) is warranted.At this time, there is not enough information and a capa will not be initiated.It is possible that the device or equipment the syringe was connected to, or the solution drawn into the syringe may have led to an occlusion causing pressure to build during use, leading to the syringe to crack.Another possible cause may be if too much pressure is applied to a plunger in relation to the viscosity of the solution being expelled.This may lead to excess pressure within the syringe also potentially resulting in the syringe cracking during use.

• Brand Name: 20ML SYR LUER LOCK TIP
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 11688615
• MDR Text Key: 249059330
• Report Number: 1915484-2021-01232
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521010802
• UDI-Public: 10884521010802
• 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: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1182000777
• Device Catalogue Number: 1182000777
• Device Lot Number: 028012X
• Date Manufacturer Received: 04/14/2021
• Patient Sequence Number: 1