MAUDE Adverse Event Report: ANGIODYNAMICS LIFEGUARD INFUSION SET; LIFEGUARD INFUSION SET

Model Number LG-20-75

Device Problem Protective Measures Problem (3015)

Patient Problems Perforation (2001); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2022

Event Type  malfunction  

Manufacturer Narrative

The reported device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

A nurse reported an issue with a 20 gauge lifeguard safety needle.After performing an injection on a patient, the nurse was poked in the left thumb with the contaminated needle when disposing of it.This occurred due to the safety feature failing to function.It was reported that when the safety feature was engaged, the needle was still able to come out of the safety feature.It was also reported that the white wings on the device still move back and forth when the yellow safety feature is in place.The nurse did not require any type of post-exposure prophylaxis or treatment.

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.A same lot number needle sample (unused) was returned for evaluation and no issues were observed during needle evaluation, i.E.Safety mechanism functioned/locked as intended.The customer's reported complaint description of "the needle's safety feature does not work" was not confirmed, as the used complaint sample was discarded and not returned for evaluation of the safety mechanism.Without receiving a complaint sample for evaluation a definitive root cause for this event cannot be determined.A potential root cause for needle stick injury is end user not fully pulling wings back (and needle) into yellow safety mechanism such that needle locks into place.In addition, when needle is locked into place the needle stick guard can flip over the end of the yellow safety housing further preventing needle from coming out.Labeling review: instructions for use that is provided with this device contains the following statements: caution: single use only: non-pyrogenic, non-toxic.Contents sterile unless package is opened or damaged.Do not resterilize.Carefully read and follow all instructions prior to use of the device.Follow cdc guidelines, institutional guidelines or ins and ons guidelines for infusion set use.Always maintain universal precautions and utilize aseptic technique throughout insertion care and maintenance procedures.Application of excessive force to needle while accessing port may result in damage to needle and port.Leakage of fluid may occur when disconnecting components.Keep hand/fingers protected from needle tip at all times by following the instructions for use.Do not attempt to override the safety feature.Removal: raise the needle trap to a 90° angle (see figure b-page 8).Using your non-dominant hand, grasp the needlestick guard with your thumb and index finger.Gently push the needlestick guard down against the patient's port.While securely holding the needlestick guard in place, use your dominant hand to grasp the flexible wings and pull upward until the needle is completely encapsulated in the needle trap (see figure c-page 8).Note: the needle trap allows for visual confirmation that the needle is fully encapsulated and safe.Additionally, you will hear it lock into the safe position.Flip the needlestick guard towards the needle trap (see figure d-page 8).Properly dispose in sharps container.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

• Brand Name: LIFEGUARD INFUSION SET
• Type of Device: LIFEGUARD INFUSION SET
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 14135569
• MDR Text Key: 298879630
• Report Number: 1317056-2022-00070
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: H787LG20755
• UDI-Public: H787LG20755
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013871
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LG-20-75
• Device Catalogue Number: LG2075
• Device Lot Number: 5704720
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1