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

Model Number	8881513934
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 the staff noticed a broken syringe before using.Upon review of the provided photograph, the luer tip is broken.
Additional Manufacturer Narrative
H 3 evaluation summary: the device history record (dhr) for the reported lot no issues were found in visual and physical samples inspected from the lot.A review of the dhr found no manufacturing or inspection anomalies indicative of syringe defect.No maintenance records were created related to the reported condition.All scheduled maintenance and calibration activities were completed on time.Process monitoring data was reviewed and equipment issues related to the reported condition were observed.A review of the machine setup was conducted and did not identify any issues.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, samples are visually inspected for damage and missing components.The lot met all defined acceptance requirements and was released.There were samples and pictures submitted with this complaint.The reported condition was confirmed showing the full removal of the luer from the barrel.The exact root cause of the reported condition could not be determined as no corroborating evidence could be found within documentation review.The most likely cause of the failure is due to machine damage stemming from loader jam as the downtime report does mention loader issues.A specific root cause could not be determined based on available information.There¿s no indication of a systemic issue with the product or process, so a corrective and preventative action (capa) will not be issued at this time.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: 3ML SYRINGE LUER LOCK TIP RP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 10465105
• Report Number: 1017768-2020-00843
• Device Sequence Number: 19583541
• Product Code: FMF
• UDI-Device Identifier: 20884521012858
• UDI-Public: 20884521012858
• Combination Product (Y/N): N
• Initial Reporter State: AS
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

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: 8881513934
• Device Catalogue Number: 8881513934
• Device Lot Number: 013246
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 11/19/2020
• Patient Sequence Number: 1