ROSENTHAL NEEDLE 18G X 1" 7558

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-12-20 for ROSENTHAL NEEDLE 18G X 1" 7558 manufactured by Popper Precision Instruments.

Event Text Entries

[212628] Needle broke during a procedure. The broken part was removed from the pt without injury.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2414164-2001-00002
• MDR Report Key: 369670
• Date Received: 2001-12-20
• Date of Event: 2001-12-11
• Date Facility Aware: 2001-12-11
• Date Reported to FDA: 2001-12-20
• Date Reported to Mfgr: 2001-12-19
• Date Added to Maude: 2002-01-07
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• 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: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ROSENTHAL NEEDLE 18G X 1"
• Generic Name: REUSABLE BONE MARROW BIOPSY NEEDLE
• Product Code: GDM
• Date Received: 2001-12-20
• Returned To Mfg: 2001-12-19
• Model Number: NA
• Catalog Number: 7558
• Lot Number: *
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: 3 YR
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 358799
• Manufacturer: POPPER PRECISION INSTRUMENTS
• Manufacturer Address: 267 JENCKES HILL RD. LINCOLN RI 02865 US
• Baseline Brand Name: ROSENTHAL NEEDLE
• Baseline Generic Name: ROSENTHAL REUSABLE BONE MARROW BIOPSY NDL 18G X 1"
• Baseline Model No: NA
• Baseline Catalog No: 7558
• Baseline ID: 18G X 1"
• Baseline Device Family: BIOPSY NEEDLE - REUSABLE
• Baseline Shelf Life Contained: N
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: Y
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2001-12-20