MAUDE Adverse Event Report: DUOPROSS MEDITECH (KUNSHAN) CO., LTD. DPS BARE HYPODERMIC SYRINGES 3 ML; SYRINGE, PISTON

Catalog Number 100000000171

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/06/2021

Event Type  malfunction  

Event Description

Dps bare hypodermic syringes and dps safety needles treatment under emergency use authorization(eua): the plunger cracked upon drawing up the moderna vaccine; the white hub at the base of the needle was blowing air; when the nurse went to inject the vaccine into the patients left deltoid, the vaccine started leaking out; the hub of the needle was secure on the syringe; since majority of the vaccine was not delivered to patient, a new vaccine syringe was administered to patient in right deltoid; followed cdc guidelines distributed by duopross meditech corp; (b)(6) syringe and needles supplied with the vaccine ancillary kits.Dps bare hypodermic syringe 3 ml lot# unknown; ref 100000000171, dps safety needle 23g x 1 1/2"; lot # unknown; ref 100800000065.Fda safety report id# (b)(4).

• Brand Name: DPS BARE HYPODERMIC SYRINGES 3 ML
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): DUOPROSS MEDITECH (KUNSHAN) CO., LTD.
• MDR Report Key: 11655189
• MDR Text Key: 245337245
• Report Number: MW5100707
• Device Sequence Number: 1
• Product Code: FMF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/09/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 100000000171
• 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
• Patient Age: 63 YR