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

Model Number	1180320112
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2020
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.This was noticed in the rheumatology department while administering.There was no harm to the patient.
Additional Manufacturer Narrative
A review of the device history record 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 were submitted for analysis as well photographs that confirmed the reported condition.The most likely cause for the reported condition could occur during the manufacturing process when loading the machine which would be indicative of the positioning foot not contacting the finger rests as intended.The cracked barrels also exhibit abrasions near the finger rests of the syringe.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, at this time a corrective and preventive action (capa) is not necessary.

• 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: 9615617
• Report Number: 1017768-2020-00778
• Device Sequence Number: 546929
• 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): 03/17/2020

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: 03/17/2020
• Patient Sequence Number: 1