VDRL ANTIGEN WITH BUFFERED SALINE FOUND IN 240764

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-11-09 for VDRL ANTIGEN WITH BUFFERED SALINE FOUND IN 240764 manufactured by Becton, Dickinson And Company (bd).

Event Text Entries

[3075508] Failure of manufacturer to respond upon notification of product defect. Kit lot #217481 and 2167335 each contain buffered saline lot #2160058. The kit directions specify: "check the ph of the vdrl buffered saline before preparing the vdrl antigen suspension. Discard if outside the range of ph 6. 0 +/- 0. 1". Upon opening kit catalog #240765, lot# 2167335 on (b)(6) 2012, the ph for buffered saline lot # 2160058 was found to be out of range. Testing was stopped. Bd was notified of defect on the same day. After multiple calls, bd sent catalog # 240764, lot# 2174181 which contained the same lot # 2160058 buffered saline, also found to have ph out of range. When requested, bd reported they had no alternate lot number of buffered saline on hand. Though bd promised to test the ph of lot # 2160058 buffered saline on hand at their site and to test the container of defective buffered saline returned to bd for sampling, no info has been forthcoming from bd except to say the investigation will take 30-45 days. In the meantime, bd said they would send 3 bottles of buffered saline for delivery on (b)(6) 2012. Only 1 bottle was received and it passed qc. Bd said that once that bottle which was specially prepared for our use is exhausted there is no alternative supply. Bd has been so reluctant to provide any info, it is feared that bd is knowingly continuing to sell defective product. Though use of an infectious disease specialty list-server, it is now know that our facility is not alone in having recognized this issue. The additional facility contacted bd and has received no positive response from bd. Following our investigation, doing parallel testing using defective buffered saline and acceptable buffered saline, the test results are shown to be impacted by the out-of-range ph. The defective buffered saline should be recalled. Pt results and treatment decisions are affected.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5027626
• MDR Report Key: 2834862
• Date Received: 2012-11-09
• Date of Report: 2012-11-09
• Date of Event: 2012-10-29
• Date Added to Maude: 2012-11-20
• 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: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: VDRL ANTIGEN WITH BUFFERED SALINE
• Generic Name: VDRL BUFFERED SALINE
• Product Code: GMT
• Date Received: 2012-11-09
• Catalog Number: FOUND IN 240764
• Lot Number: 2160058
• Device Expiration Date: 2015-05-31
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BECTON, DICKINSON AND COMPANY (BD)
• Manufacturer Address: 7 LOVETON CIRCLE SPARKS MD 21152 US 21152

Device Sequence Number: 2

• Brand Name: VDRL TEST CONTROL SERUM SET
• Generic Name: VDRL BUFFERED SALINE
• Product Code: GMT
• Date Received: 2012-11-09
• Catalog Number: 240765
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: BECTON, DICKINSON AND COMPANY (BD)
• Manufacturer Address: 7 LOVETON CIRCLE SPARKS MD 21152 US 21152

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-11-09