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 Consequences Or Impact To Patient (2199)
Date of Event	10/11/2019
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 one of their phlebotomist noticed the 3ml syringe was cracked, resulting in a redraw.
Additional Manufacturer Narrative
Additional information: the device history record (dhr) for the reported lot indicates no issues were found in visual and physical samples inspected from the lot.There were no samples submitted with this complaint.The reported condition was confirmed from a review of a picture provided of three syringes in an opened state.The exact root cause could not be determined as no documentation could be found that supported this type of failure.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.Therefore, a corrective and preventive action (capa) is not necessary at this time.This information will be utilized for trending purposes to determine the need for corrective actions.

• 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: 9238454
• Report Number: 1017768-2019-00714
• Device Sequence Number: 11294102
• Product Code: FMF
• UDI-Device Identifier: 10884521012295
• UDI-Public: 10884521012295
• 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: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2020

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: 10/11/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 02/03/2020
• Patient Sequence Number: 1