MAUDE Adverse Event Report: COVIDIEN 3ML SYRINGE LUER LOCK TIP; SYRINGE, PISTON

Model Number 1180300777

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 07/08/2019

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 they found cracked syringes in inventory.This was discovered before use.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Prior to a lot¿s release, the lot must be deemed acceptable by-passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.Specifically, a lot met all defined acceptance requirements and was released.There were four samples received for the evaluation.Upon visual examination, the reported condition is confirmed.The exact root cause of the reported condition could not be determined, as no documented evidence could be attributed to the issue identified within the sample¿s evaluation.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.

• Brand Name: 3ML SYRINGE LUER LOCK TIP
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 8780453
• MDR Text Key: 150704243
• Report Number: 1017768-2019-00655
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521012301
• UDI-Public: 10884521012301
• 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: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1180300777
• Device Catalogue Number: 1180300777
• Device Lot Number: 908658
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/08/2019
• Initial Date FDA Received: 07/11/2019
• Supplement Dates Manufacturer Received: 07/08/2019
• Supplement Dates FDA Received: 11/15/2019
• Patient Sequence Number: 1