MAUDE Adverse Event Report: GREINER BIO-ONE NA INC VACUETTE TUBE 4 ML LH LITHIUM HEPARIN 13X75 GREEN CAP-BLACK RING, NON-RIDGED; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number 454029

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Gbo complaint (b)(4).No samples were received for evaluation.We have no further inventory of the material/batch.We have further complaints on the material/batch.No clarification or further information was received from the customer.A review of quality, production and maintenance records revealed no deviations in relation to the reported error.The complaint can not be determined.

Event Description

Customer states a greiner tube had about 1ml of anticoagulant, and added that usually the anticoagulant is not discernable.

• Brand Name: VACUETTE TUBE 4 ML LH LITHIUM HEPARIN 13X75 GREEN CAP-BLACK RING, NON-RIDGED
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): GREINER BIO-ONE NA INC; 4238 capital drive; monroe, nc
• Manufacturer (Section G): GREINER BIO-ONE NA INC; 4238 capital drive; monroe, nc
• Manufacturer Contact: manfred abel ; 4238 capital drive; monroe, nc ; 2617800782
• MDR Report Key: 10463354
• MDR Text Key: 207945989
• Report Number: 1125230-2020-00016
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960857
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2021
• Device Model Number: 454029
• Device Catalogue Number: 454029
• Device Lot Number: B200136L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1