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

Model Number	8881516200
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2019
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 while the doctor was doing a block, the syringe squirted out the side.It did not hit the patient or the doctor, there was no injury to the patient or the doctor, however, as a precaution the doctor ordered iv antibiotics.
Additional Manufacturer Narrative
Two samples outside of the original package with no lot number was received for evaluation.After a visual inspection, the syringe was found to be leaking.The device history record (dhr) file was reviewed indicating that product was released meeting all quality standard requirements.The finished component for the monoject 6ml syringe, luer lock tip, is manufactured by a separate manufacturing site from the investigation and the assembly site which consists of a pick and place operation into a tray.The condition reported is not generated during the pick and place operation.A complaint notification was sent to the manufacturing site to initiate and investigate the root cause.A formal investigation was opened in order to determine the root cause and implement the appropriated corrective action(s) and preventative actions (capa).Subsequently, the corrective actions will be addressed on capa investigation.

• Brand Name: 6ML LUER LOCK PHARMACY TRAY
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 8627929
• Report Number: 9612030-2019-02185
• Device Sequence Number: 2169009
• Product Code: FMF
• UDI-Device Identifier: 10884521012127
• UDI-Public: 10884521012127
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: 8881516200
• Device Catalogue Number: 8881516200
• Device Lot Number: 1823913364
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 10/07/2019
• Patient Sequence Number: 1