MAUDE Adverse Event Report: COVIDIEN 6ML SYRINGE REGULAR TIP NS; SYRINGE, PISTON

Model Number	8881106028
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2019
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 reports the syringe was being used to inflate a balloon with a mixed liquid however, the mixed liquid was just leaking out of the syringe because of a hole near the graduation marking.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Physical samples were not received for the investigation, but three photographs were provided.In the first photograph, a syringe (unknown capacity) is observed connected to another component and is filled with a blue tinted liquid.On the tip, shoulder, and top portion of the syringe, droplets of the blue liquid can be observed.In the second photograph provided, a closer visual of the same syringe can be observed.A red circle is placed on the photograph highlighting a large droplet of the blue liquid on the shoulder area of the syringe.In the third photograph, three magnified photographs of the same empty syringe (no blue liquid observed) are shown with red arrows highlighting the same section of the shoulder of the barrel.There is also a close-up photograph (magnified 50x) of the same area which is circled in red highlighting a small hole just above the gate location of the molded barrel component.Although the condition of a hole in the molded barrel component appears to be confirmed per the photographs provided, without a sample, a complete investigation cannot be performed at this time and the reported condition cannot be confirmed.A root cause could not be determined as the reported issue was not confirmed.If the sample is returned in the future, this complaint will be re-opened and the investigation will be updated accordingly.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.However, these conditions will be communicated to the appropriate manufacturing and quality assurance personnel.This complaint will be used for qa tracking and trending purposes.

• Brand Name: 6ML SYRINGE REGULAR TIP NS
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 8693235
• Report Number: 1915484-2019-01056
• Device Sequence Number: 1924800
• Product Code: FMF
• UDI-Device Identifier: 10884521013896
• UDI-Public: 10884521013896
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2019

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: 8881106028
• Device Catalogue Number: 8881106028
• Device Lot Number: 729219X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 10/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1