MAUDE Adverse Event Report: AMERICORD NEONATAL BLOOD COLLECTION KIT AND SCREENING FORM

Device Problems Device Disinfection Or Sterilization Issue (2909); Packaging Problem (3007)

Patient Problem No Information (3190)

Event Date 11/13/2017

Event Type  No Answer Provided  

Event Description

Fetal cord blood collection kit (americord) has incorrect packaging for use during surgery (cesarean section).If product is used as directed, you are pulling a sterile cord blood collection bag through a torn (non-sterile) opening, which makes it virtually impossible to maintain sterility when passing onto the sterile field.Mothers are being put at risk of a surgical site infection if this product is used.

• Brand Name: NEONATAL BLOOD COLLECTION KIT AND SCREENING FORM
• Type of Device: BLOOD COLLECTION KIT
• Manufacturer (Section D): AMERICORD ; 139 fulton st; ste 707; new york NY 10038
• MDR Report Key: 7037466
• MDR Text Key: 92313993
• Report Number: MW5073369
• Device Sequence Number: 1
• Product Code: OIA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1