MAUDE Adverse Event Report: DPS BARE / DUOPROSS MEDITECH CORPORATION DPS HYPODERMIC SYRINGE LUER LOCK; SYRINGE, ANTISTICK

Lot Number 2011012

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

[dps bare hypodermic syringe] use for covid-19 under emergency use authorization (eua): state ancillary supplies- dps bare hypodermic syringe, 1ml.Lot # 20110012, exp date: 11-15-2025.Syringe barrel has huge hole in it.Fda safety report id# (b)(4).

• Brand Name: DPS HYPODERMIC SYRINGE LUER LOCK
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): DPS BARE / DUOPROSS MEDITECH CORPORATION ; cn
• MDR Report Key: 11998676
• MDR Text Key: 256453138
• Report Number: MW5101869
• Device Sequence Number: 1
• Product Code: MEG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 2011012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1