MAUDE Adverse Event Report: GREINER BIO-ONE GMBH MINICOLLECT COMPLETE 1ML 9NC; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number 450556

Device Problems Nonstandard Device (1420); Short Fill (1575)

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

Event Type  Injury  

Manufacturer Narrative

The above mentioned capillary blood collection tube partly shows not enough additive which might cause falsification of analysis results, if the collected blood samples is used for analysis.Although the deviation of amount of additive could be detected by the user, it was decided to recall the complete batch of the affected item.The distributor and user will be advised to send back all products of the affected item or scrap the products and confirm the scrapping to the manufacturer.No complaint report and no mdr because it is a follow up/extension of recall r006_17.

Event Description

Customer claimed that no or less liquid additive is in the tube.

• Brand Name: MINICOLLECT COMPLETE 1ML 9NC
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): GREINER BIO-ONE GMBH; bad haller strasse 32; kremsmuenster, 4550 ; AU 4550
• Manufacturer (Section G): GREINER BIO-ONE NA; 4238 capital drive; monroe NC 28110
• Manufacturer Contact: manfred abel ; 4238 capital drive,; monroe, NC 28110 ; 7042617800
• MDR Report Key: 9742335
• MDR Text Key: 190509708
• Report Number: 8020040-2018-00009
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 450556
• Device Catalogue Number: 450556
• Device Lot Number: A17044CM, A171144P, A17093C9
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention