S/P BLOOD GAS CAPILLARY COLLECTION SET B6697-2L

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-06-18 for S/P BLOOD GAS CAPILLARY COLLECTION SET B6697-2L manufactured by Kimble Chase Life Science And Research Products Llc.

Event Text Entries

[16700750] Capillary tubes are designed to prevent clotting for whole blood analysis for ph, po2 and pco2. This lot (551) of capillary gas tubes consistently clots requiring re-collection of specimens. This has happened at least 10-15 times over the last 6-8 weeks. Upon initial incident of specimens clotting we called our vendor. They shipped us a new kit (realized that it was the same lot #) in the mean time, we found a number of capillary tubes from an old lot number and utilized them. Once again when we opened the new kit (551), the capillary specimen started to clot. We once again contacted our vendor and they stated that they could not get a new lot # from the company as they were not available to date and the company suggested that nothing was wrong with the product as they had not heard and complaints from other organizations. At this time, we looked for a replacement product and found one that not only met our needs but was also made of plastic instead of glass. We completely ran out of the old lot number by this time and was unable to do a comparison between the new capillary tube and the old glass capillary tubes. Each time we would draw a specimen in the old capillary tube product, it would immediately clot. After a couple of weeks, we finally got a new lot number of the glass capillary tubes to complete our comparisons. Dates of use: 2009. Diagnosis or reason for use: premature infant respiratory monitoring.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5011592
• MDR Report Key: 1404743
• Date Received: 2009-06-18
• Date of Report: 2009-06-04
• Date of Event: 2009-05-01
• Date Added to Maude: 2009-06-24
• 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: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• 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 Details

• Brand Name: S/P BLOOD GAS CAPILLARY COLLECTION SET
• Generic Name: CAPILLARY GAS KIT
• Product Code: GIO
• Date Received: 2009-06-18
• Catalog Number: B6697-2L
• Lot Number: 551
• Device Expiration Date: 2010-08-31
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: KIMBLE CHASE LIFE SCIENCE AND RESEARCH PRODUCTS LLC
• Manufacturer Address: 1022 SPRUCE STREET PO BOX 1502

Patients

Patient Number	Treatment	Outcome	Date
1	0		2009-06-18