MAUDE Adverse Event Report: NIPRO (THAILAND) CORP. LTD. NIPRO 3CC SYRINGE WITH NEEDLE; DISPOSABLE SYRINGE

Model Number JD+03L2219

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

Facility reported two needles breaking when giving im(intramuscular) injections.No additional information has been provided, date of event is unknown.

• Brand Name: NIPRO 3CC SYRINGE WITH NEEDLE
• Type of Device: DISPOSABLE SYRINGE
• Manufacturer (Section D): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8; bangnomko,; sena, ayuthaya 13110 ,; TH 13110,
• MDR Report Key: 13051775
• MDR Text Key: 282553542
• Report Number: 1056186-2021-00016
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00383790000758
• UDI-Public: 00383790000758
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JD+03L2219
• Device Lot Number: 20I04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/21/2021
• Distributor Facility Aware Date: 11/19/2021
• Device Age: 14 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention