MAUDE Adverse Event Report: COVIDIEN 3ML SYRINGE 20G X 1 1/2; SYRINGE, PISTON

Model Number	1180320112
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/08/2019
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 the device was leaking due to cracks in the body of the syringe.
Additional Manufacturer Narrative
A review of the device history record (dhr) revealed no discrepancies that may have contributed to the reported condition.All quality assurance testing is performed during the manufacturing of the product met specification requirements.Samples and photograph were received for evaluation and confirm the reported conditions.There is no documented evidence within the dhr or any other documentation that would explain the deficiency identified.The most likely cause would be due to an issue with the equipment as the cracked barrels also exhibit abrasions near the finger rests of the syringe.This is indicative of the positioning foot not contacting the finger rests as intended.This condition usually self-corrects during the manufacturing run.Based on the information available and the investigation findings, a formal investigation is not deemed necessary at this time.The reported condition could not confirm a manufacturing deficiency.If additional information is received warranting further analysis, the investigation may be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: 3ML SYRINGE 20G X 1 1/2
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 9618578
• Report Number: 1017768-2020-00782
• Device Sequence Number: 2642179
• Product Code: FMF
• UDI-Device Identifier: 10884521012325
• UDI-Public: 10884521012325
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

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: 1180320112
• Device Catalogue Number: 1180320112
• Device Lot Number: 912013
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 03/20/2020
• Patient Sequence Number: 1