MAUDE Adverse Event Report: COVIDIEN 6ML SYRINGE LUER LOCK TIP; SYRINGE, PISTON

Model Number	1180600777
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2019
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 when pulling back on the syringe the blood is bubbling and coming through.
Additional Manufacturer Narrative
H 3: evaluation summary the device history record (dhr) for the lot was reviewed.The device history record for the lot control indicates that product and specification requirements were met with no non-conforming product identified relating to this customer report.The manufacturing site received 12 samples for evaluation.Visual inspection of the syringe assemblies revealed two of the samples were confirmed to contain the issue of a damaged barrel ¿ non-functional.The same two syringes with the damaged barrel also failed leak testing.Upon further investigation, both of the confirmed defects were found to have been produced from the same barrel mold cavity.The most probable root cause for the hole in the barrel wall was a result of a short shot in the molded barrel component of the cavity.This issue is a cavity-specific problem; however, this issue can occur sporadically from shot-to-shot.Per procedure, complaint trends are evaluated during the monthly corrective and preventative action (capa) meeting to determine if a capa is warranted.At this time, there is not enough information and a capa will not be initiated.However, these conditions will be communicated to the appropriate manufacturing and quality assurance personnel.This complaint will be used for tracking and trending purposes.

• Brand Name: 6ML SYRINGE LUER LOCK TIP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 8790124
• Report Number: 1915484-2019-01060
• Device Sequence Number: 2638855
• Product Code: FMF
• UDI-Device Identifier: 10884521013582
• UDI-Public: 10884521013582
• 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): 10/11/2019

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: 1180600777
• Device Catalogue Number: 1180600777
• Device Lot Number: 905641X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 10/11/2019
• Patient Sequence Number: 1