MAUDE Adverse Event Report: GREINER BIO-ONE NORTH AMERICA, INC. PURPLE TOP TEST TUBE; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number 454209

Device Problems Contamination (1120); Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The ma dph childhood lead poisoning prevention program has identified 6 children, to date, whose blood was drawn and collected in purple top test tubes that were likely not pre-screened for lead contamination.Test results for these children were all venous >9 and upon re-screen were < 3.5.The manufacturer identified was greiner greiner ref: 454209, lot: b220634d, lot: b220634e, information provided to us by quest (b)(6) and greiner -lot b220634a identified by life lab in (b)(6).While there is no public health risk from falsely high results, when a child under 6 has a lead test indicating lead poisoning and the child's home is built before 1978, then ma clppp moves quickly to schedule a mandatory lead inspection and clppp will issue an order to remediate any lead violations found.Such remediation can be thousands of dollars and can result in court intervention.If this is a widespread issue, it diverts clppp resources away from children who are truly poisoned and could undermine the medical community's faith in testing reliability, clppp's authority, and causes additional invasive venipuncture re-screening for the child.After speaking with the manufacturer, we understand that their could be hundred's of thousands of test tubes potentially contaminated and we do not have the capacity to trace lots, distribution, etc.We have alerted the cdc lppp of the issue.Fda safety report id# (b)(4).

• Brand Name: PURPLE TOP TEST TUBE
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): GREINER BIO-ONE NORTH AMERICA, INC.
• MDR Report Key: 15626037
• MDR Text Key: 302245427
• Report Number: MW5112689
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/14/2022
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 454209
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other