MAUDE Adverse Event Report: COVIDIEN MONOJECT; SYRINGE, PISTON

Model Number 1180600777

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date: 06/01/2017.An investigation is currently underway.Upon completion, the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reported that this product pulls air when trying to use this device for blood collection.

Manufacturer Narrative

The device history record (dhr) for lot # 703151x was reviewed and indicates that there were no observed issues reported in the dhr.The dhr confirms that the product was produced accomplishing quality requirements and released according to established procedures with no non-conformance reports identified relating to this customer report.Inspectors routinely examine the product to ensure it meets acceptable quality level (aql) sampling criteria.Some potential defects that are inspected for include, but are not limited to holes in any of the molded components, bubbles, flash, and short shots.Other physical tests are performed throughout each shift of production including gauging of the inner dimension of the barrels and leak testing to inspect for any possible leakage at the junction of the hub and luer taper or leakage past the rubber tip connected to plunger.In addition to visual and physical tests performed throughout the entire length of production, various process parameters are monitored and maintained within established validated parameters.A lot cannot be released unless it passes all visual and physical testing requirements according to established aql standards.The most likely potential factors that may contribute to a syringe pulling air during blood collection could be from the connection of other potential components used during the process or the technique used during the blood collection process.The medtronic 6 ml luer lock syringe noted by the customer in relation to this reported issue is not produced with a needle or any other device attached.Therefore, in order for the syringe to be used for blood collection, it is possible a disposable needle or other device was attached by the user to be used in this manner.If the needle or other device is not connected to the syringe tightly enough, an air leak can occur.Another potential factor would be if the user draws back too fast.Since a sample was not provided, a complete investigation cannot be performed to the full extent.Therefore, the reported condition cannot be confirmed.Although the reported issue was not able to be replicated throughout the investigation, opportunities for some improvements throughout the process were noted and preventative measures were taken, but no root cause was able to be determined.The effectiveness checks were completed successfully.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MONOJECT
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701 9062
• Manufacturer (Section G): COVIDIEN; 1222 sherwood rd; norfolk NE 68701 9062
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6604593
• MDR Text Key: 76419169
• Report Number: 1915484-2017-05029
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1180600777
• Device Catalogue Number: 1180600777
• Device Lot Number: 703151X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1