MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASYTOUCH; FLIPLOCK SAFETY SYRINGE

Catalog Number 812501

Device Problems Mechanical Problem (1384); Unintended System Motion (1430); Use of Device Problem (1670); Unintended Movement (3026)

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/17/2022

Event Type  malfunction  

Manufacturer Narrative

According to the analysis of the survey results, due to the small size of the needle tube, when the safety mechanism is activated (quickly activated) by unconventional manipulations, occasional needle tube bending occurs.

Event Description

Referencing medwatch report # mw5112793 on by a health profession (b)(6)2022, regarding ss item 812501 lot 52383.Date of event occurred on (b)(6)2022, reported to medwatch on (b)(6)2022.Event described as such: "after giving a flu shot to patient and flipping up the needle guard, it was noted that the needle was not covered by the guard and was bent; the needle was sticking out at an angle.The needle should have been covered by the needle guard.Fda safety report id # (b)(4)." initial reporter was contacted regarding discrepancies in the medwatch report that mhc received.Initial reporter identified there was a serious injury but did not provide details stating there was an accidental needlestick.Upon follow-up, the initial reporter made it known that an accidental needlestick occurred.Immediate action taken is the initiation of capa-000007-2022.

• Brand Name: EASYTOUCH
• Type of Device: FLIPLOCK SAFETY SYRINGE
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield OH 45011
• Manufacturer (Section G): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield OH 45011
• Manufacturer Contact: caitlyn gall ; 8695 seward road; fairfield, OH 45011
• MDR Report Key: 15785348
• MDR Text Key: 307681656
• Report Number: 3005798905-2022-03082
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 11/11/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 812501
• Device Lot Number: 52383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2022
• Initial Date FDA Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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