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

Model Number	1180300777
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported that the syringes were found to be cracked inside of the individual package.There was no patient harm.
Additional 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 pictures submitted for the evaluation.Upon analyzing the pictures, the reported condition is confirmed.The exact root cause of the reported condition could not be determined.The investigation did not identify a systemic issue with the product or the manufacturing process.A corrective action is not applicable at this time.If a physical sample is returned in the future, this complaint will be re-opened for further investigation.This complaint will be used for qa tracking and trending purposes.

• Brand Name: 3ML SYRINGE LUER LOCK TIP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 8785361
• Report Number: 1017768-2019-00656
• Device Sequence Number: 1707777
• Product Code: FMF
• UDI-Device Identifier: 10884521012301
• UDI-Public: 10884521012301
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Model Number: 1180300777
• Device Catalogue Number: 1180300777
• Device Lot Number: 908658
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 11/15/2019
• Patient Sequence Number: 1