NI 811011400

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-06-02 for NI 811011400 manufactured by Medical Device Technologies, Inc..

Event Text Entries

[17107510] Bone marrow biopsy complicated by difficulty in withdrawing the core of marrow from the trochar needle. The core appeared to be stuck/jammed at the distal end, requiring vigorous manipulation of sampling stylette. Unfortunately, the head to the core-sample stylette broke off. User had to withdraw the stylette with a set of surgical clamps, needless to say, the core biopsy of marrow suffered some crush artifact. Additonally, on two separate bone marrow biopsies, have experienced significant crush artififact in sample of bone marrow biopsy. This has occurred since user started using this particular new model of bone marrow biopsy needle.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4002242
• MDR Report Key: 172792
• Date Received: 1998-06-02
• Date of Report: 1998-06-01
• Date Added to Maude: 1998-06-18
• Event Key: 0
• Report Source Code: Voluntary 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NI
• Generic Name: BONE MARROW BIOPSY SET
• Product Code: LWE
• Date Received: 1998-06-02
• Model Number: NA
• Catalog Number: 811011400
• Lot Number: 80438765
• ID Number: NI
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 168013
• Manufacturer: MEDICAL DEVICE TECHNOLOGIES, INC.
• Manufacturer Address: 4445 S.W. 35TH TERR. GAINESVILLE FL 32608 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1998-06-02