CORD BLOOD COLLECTION BAG (THE FDA-APPROVED COMPONENT OF AMERICORD'S 3-IN-1 COLL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-28 for CORD BLOOD COLLECTION BAG (THE FDA-APPROVED COMPONENT OF AMERICORD'S 3-IN-1 COLL manufactured by Americord.

Event Text Entries

[93208286] I am predispositioned for germ-line cancer and needed to preserve my daughter's stem cells (born (b)(6) 2017). I chose americord, which advertises to use a medical courier in transporting the biological specimens (cord blood, placenta tissue, and cord tissue). Despite advertising to do so, they did not use a medical courier (used a general courier company called (b)(6); phone: (b)(6)). Furthermore, the courier returned mid-transport to bring back my specimens, which had been leaking out of the kit and were permanently damaged. I noticed the bags/packaging americord provided were faulty, thereby causing leakage despite following all directions properly; this resulted in permanent loss and exposure of the remaining biological specimens to contaminants. Their website purports to offer "the only sterile, fda-approved cord blood bag, " yet this bag failed to function to maintain sterility of my irreplaceable biological specimens. I have preserved portions of the original kit and have photos of the parts prior to handling them to the courier and following the courier's return with my damaged biological specimens. Dose or amount: 1 bag. Dates of use: (b)(6) 2017. Diagnosis or reason for use: preserve cord blood and transport to americord for banking. Is the product compounded: no. Is the product over-the-counter: no. Event abated after use stopped or dose reduced: no.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5073577
• MDR Report Key: 7063395
• Date Received: 2017-11-28
• Date of Report: 2017-11-24
• Date of Event: 2017-11-01
• Date Added to Maude: 2017-11-28
• 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: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: CORD BLOOD COLLECTION BAG (THE FDA-APPROVED COMPONENT OF AMERICORD'S 3-IN-1 COLL
• Generic Name: BLOOD COLLECTION BAG
• Product Code: KSR
• Date Received: 2017-11-28
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: AMERICORD

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Other	2017-11-28