ASPIRATING SYRINGE * 76-70

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-07-26 for ASPIRATING SYRINGE * 76-70 manufactured by Miltex Instrument Co., Inc..

Event Text Entries

[158472] Bottom section of syringe came apart during actual use. Disassembly occurred at winged area and internal spring hit patient in her cheek.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2431021-1999-00003
• MDR Report Key: 233841
• Report Source: 05
• Date Received: 1999-07-26
• Date of Report: 1999-07-23
• Date of Event: 1999-07-12
• Date Mfgr Received: 1999-07-12
• Date Added to Maude: 1999-08-02
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ASPIRATING SYRINGE
• Generic Name: TPYE "C-W"
• Product Code: EJI
• Date Received: 1999-07-26
• Returned To Mfg: 1999-07-16
• Model Number: *
• Catalog Number: 76-70
• Lot Number: UNK
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 226651
• Manufacturer: MILTEX INSTRUMENT CO., INC.
• Manufacturer Address: 700 HICKSVILLE RD. BETHPAGE NY 11714 US
• Baseline Brand Name: ASPIRATING SYRINGE
• Baseline Generic Name: TYPE "C-W"
• Baseline Model No: 76-70
• Baseline Catalog No: 76-70
• Baseline ID: SYRINGE 1.8CC T
• Baseline Device Family: SYRINGE, CARPULE
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: Y
• Baseline Transitional: N
• 510k Exempt: Y

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-07-26