MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD MICROTAINER MAP K2EDTA 1.0 MG; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number 363706

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 09/16/2021

Event Type  malfunction  

Event Description

Narrative from staff: rn drew sample for a cbc (complete blood count) from a umbilical artery catheter and sent it to the lab in a lavender microtainer and it ended up clotting.Staff drew a second from the umbilical artery catheter and it also clotted.Then, a third draw sample from the umbilical artery catheter and it clotted as well.A fourth sample from the umbilical artery catheter was drawn and a microtainer was used from a different lot number and it did not clot.We are suspicious that it may be the batch of tubes and have pulled them from the supply area.Manufacturer response for bd microtainer map, (brand not provided) (per site reporter): we have contacted the manufacturer representative.

• Brand Name: BD MICROTAINER MAP K2EDTA 1.0 MG
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12576286
• MDR Text Key: 274794006
• Report Number: 12576286
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/21/2021

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?: Yes
• Device Operator: Other
• Device Model Number: 363706
• Device Catalogue Number: 363706
• Device Lot Number: 1040043
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Weight: 1