MAUDE Adverse Event Report: AMERICORD CORD BLOOD COLLECTION BAG (THE FDA-APPROVED COMPONENT OF AMERICORD'S 3-IN-1 COLL

Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2017

Event Type  Injury  

Event Description

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.

• Brand Name: CORD BLOOD COLLECTION BAG (THE FDA-APPROVED COMPONENT OF AMERICORD'S 3-IN-1 COLL
• Type of Device: BLOOD COLLECTION BAG
• Manufacturer (Section D): AMERICORD
• MDR Report Key: 7063395
• MDR Text Key: 93208286
• Report Number: MW5073577
• Device Sequence Number: 1
• Product Code: KSR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Weight: 79