MAUDE Adverse Event Report: COVIDIEN UNKNOWN NEEDLES AND SYRINGES; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881250313
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that it is unknown the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
Customer reports: reflux of the vaccine occurred between the insertion of the needle into the syringe therefore there is a loss of approximately 0.15 ml of product.
Additional Manufacturer Narrative
After reviewing the new information provided it was determined that this report was submitted with an unknown product code.The product identification was provided on 4/16/21 and a new report will be filed.& nbsp; please disregard report number & nbsp; 1017768-2021-00919.
Additional Manufacturer Narrative
The device history record (dhr) for the reported lot indicates that there were no anomalies found in visual samples inspected from the lot and no non-conformance reports issued for this lot.Prior to a lot¿s release, the lot must be deemed acceptable, passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.Specifically, samples are inspected for leakage in the fluid pathway.The lot met all defined acceptance requirements and was released.There were 2 needles unused, unopened returned with this complaint.Additionally, two (unused, unopened) 1 ml syringes were submitted with the complaint.The syringes are manufactured by a non-cardinal health company and the needles were visually inspected, and no deviations were encountered.The needles were physically tested per the leakage test for single point needles, hubs, filter connectors, and fractured components by using the single-station water leakage tester which is set at 45 +5, -0 psi.None of the samples leaked from the fluid path needle nose, luer.Cardinal health (cah) is not responsible for testing product made outside cah control.For the sake of the investigation, the syringes made by pinto med were opened and tested to determine if any leakage was observed.No leakage in the fluid path needle nose, luer was detected.The reported condition could not be confirmed.A specific root cause could not be determined based on the available information.There¿s no indication of a systemic issue with the product or process, so a formal corrective and preventative action (capa) will not be issued at this time.

• Brand Name: UNKNOWN NEEDLES AND SYRINGES
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 11620315
• Report Number: 1017768-2021-00919
• Device Sequence Number: 11578920
• Product Code: FMI
• UDI-Device Identifier: 20884521013831
• UDI-Public: 20884521013831
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 07/19/2021

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: 8881250313
• Device Catalogue Number: 8881250313
• Initial Date Received by Manufacturer: 04/02/2021
• Supplement Date Received by Manufacturer: 04/02/2021; 04/02/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 04/20/2021; 07/19/2021
• Patient Sequence Number: 1