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)
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 during administering, leaking was noticed due to cracks in the body of the syringe.This was happened in the rheumatology department.There was no harm to the patient involved.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A review of maintenance records (both corrective and preventive) and calibration records were reviewed and there were no issues.All scheduled maintenance and calibration activities were completed.There were no related process or material changes related to the reported condition for this product or describe changes that occurred.Few samples and pictures were provided for the evaluation.Upon evaluation, the reported condition is confirmed.The most likely cause would be due to a loading issue at the ram as the cracked barrels also exhibit abrasions near the finger rests of the syringe.This is an indicative of the positioning foot not contacting the finger rests as intended.This issue can be self-correcting, and the investigation did not identify any systemic issue.A corrective and preventive action (capa) is not necessary at this time.This information will be utilized for 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: 9616192
• Report Number: 1017768-2020-00780
• Device Sequence Number: 547657
• 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: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2020

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: 03/25/2020
• Patient Sequence Number: 1