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

Lot Number 2010049

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/05/2021

Event Type  No Answer Provided  

Event Description

[dps needles and syringes] treatment under emergency use.Authorization(eua): we would like to report a critical malfunction with the dps bare hypodermic syringes and safety needles supplied in our pfizer covid-19 vaccine ancillary kits.The needle and syringe combination fails to securely attach and results in the needle detaching from the syringe during vaccine administration.Upon withdrawal, the needle remains lodged in the patient's arm.Not only is this a safety issue, we have lost vaccine doses due to leaking from the hub site.

• Brand Name: DPS BARE HYPODERMIC SYRINGES
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): DPS / DUOPROSS MEDITECH (KUNSHAN) CO., LTD.
• MDR Report Key: 11494659
• MDR Text Key: 240363088
• Report Number: MW5099997
• Device Sequence Number: 2
• Product Code: FMF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/09/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 2010049
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other