VACUTAINER 21 G 1 INCH UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-11-25 for VACUTAINER 21 G 1 INCH UNK manufactured by Becton Dickinson & Co..

Event Text Entries

[116627] Rptr called to add info to a phone report taken on 11/25/1998. The first event on 12/11/1997 at a hospital involved a becton dickinson vacutainer, product info unknown. The second event on 6/26/1998 at a dr's office involved a becton dickinson precision glide, product info unkown. Rptr states that in both events, leakage occurred during transfer of tubes, when rubber cover did not provide an accurate seal.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1015047
• MDR Report Key: 198926
• Date Received: 1998-11-25
• Date of Report: 1998-11-25
• Date of Event: 1997-12-11
• Date Added to Maude: 1998-11-30
• 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
• Reporter Occupation: PATIENT
• 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 Sequence Number: 1

• Brand Name: VACUTAINER 21 G 1 INCH
• Generic Name: VACUUM ASSISTED BLOOD COLLECTION SYSTEM
• Product Code: KST
• Date Received: 1998-11-25
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 193249
• Manufacturer: BECTON DICKINSON & CO.
• Manufacturer Address: 1 BECTON DR. FRANKLIN LAKES NJ 074171880 US

Device Sequence Number: 2

• Brand Name: PRECISION GLIDE VACUTAINER
• Generic Name: MULTIPLE SAMPLE BLOOD COLLECTION NEEDLE
• Product Code: KST
• Date Received: 1998-11-25
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 2
• Device Event Key: 193936
• Manufacturer: BECTON DICKINSON & CO.
• Manufacturer Address: 1 BECTON DR. FRANKLIN LAKES NJ 074171880 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1998-11-25