MAUDE Adverse Event Report: UNKNOWN RELI-ON 31 GAUGE (15/64") LENGTH NEEDLE 1ML SYRINGE; SYRINGE, PISTON

Lot Number 9350454B

Device Problem Defective Device (2588)

Patient Problem Skin Tears (2516)

Event Date 07/18/2020

Event Type  malfunction  

Event Description

I purchased reli-on 31 gauge 6mm 100 unit insulin syringes at (b)(6).I purchased one two weeks ago in one today.In both boxes, at least 50% of the needles were defective.Rather than sliding in, they ripped the skin and caught on every layer of tissue.Both were from lot number 9350454.I've used these for years without receiving a similar defective product.I'm contacting (b)(6) pharmacy to ask that they be removed from the pharmacy shelves when they open tomorrow.Fda safety report id #: (b)(4).

• Brand Name: RELI-ON 31 GAUGE (15/64") LENGTH NEEDLE 1ML SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10307851
• MDR Text Key: 200225077
• Report Number: MW5095663
• Device Sequence Number: 2
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/18/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 9350454B
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR