MAUDE Adverse Event Report: FL136 FL-DELAND HYPO NEEDLE 25G X 1 A BEV RP; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number 8881250305

Device Problem Fluid/Blood Leak (1250)

Patient Problems Skin Inflammation/ Irritation (4545); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that it is unknown if the device will 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 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 information provided on 4/16./2021 confirms that the product code that was initially reported as unknown has been identified as 8881250305.

Event Description

Additional information provided: neither the patient nor the vaccinator was injured, but the nurse was injured (dermabrasion) when she had to unhook the needle from its plastic cap (very hard to do) during other manipulations.

Manufacturer Narrative

The following sections were updated per additional information provided on 5/19/21 from the sales representative:.

Manufacturer Narrative

A review of the device history record (dhr) did not identify any manufacturing or inspection anomalies.A review of maintenance records, both corrective and preventive and calibration records were reviewed and there were no issues related to the reported condition.All scheduled maintenance and calibration activities were completed.There were no samples returned for this complaint, however a photograph was provided.The photo was visually inspected and shows a non-cardinal health syringe and a 25 x 1¿ needle.The reported condition could not be confirmed as physical samples are required to perform the luer leak test per product specification.The exact root cause could not be determined based on available information.The 6m root cause analysis did not identify any issues with the manufacturing process that would have caused this issue.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 criteria and was released.There were no manufacturing issues related to the complaint issued for this lot and a specific root cause could not be determined based on available information.There is no indication of a systemic issue with the product or process, so a capa will not be issued at this time.

• Brand Name: HYPO NEEDLE 25G X 1 A BEV RP
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): FL136 FL-DELAND; 2010 east international speedw; deland FL 32724
• MDR Report Key: 11697196
• MDR Text Key: 249059999
• Report Number: 1017768-2021-00927
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 20884521013817
• UDI-Public: 20884521013817
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881250305
• Device Catalogue Number: 8881250305
• Device Lot Number: 908411
• Date Manufacturer Received: 04/02/2021
• Patient Sequence Number: 1