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

Model Number	1180300555
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/20/2019
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 they found cracked syringes upon opening the box.No patient involved.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Two cases of samples were received at the manufacturing site for the investigation.Upon evaluation of the samples, the reported issue was confirmed.The root cause analysis indicates that a definitive root cause could not be determined at this time.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, the lot met all defined acceptance requirements and was released.A corrective action is not applicable at this time.The investigation did not identify a systemic issue with the product or process, no trend exists for the failure mode, and a specific root cause could not be identified based on available information.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 REGULAR LUER TIP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 9375613
• Report Number: 1017768-2019-00741
• Device Sequence Number: 3103700
• Product Code: FMF
• UDI-Device Identifier: 10884521012295
• UDI-Public: 10884521012295
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 02/05/2020

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: 1180300555
• Device Catalogue Number: 1180300555
• Device Lot Number: 833204
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 02/05/2020
• Patient Sequence Number: 1