MAUDE Adverse Event Report: GREINER BIO-ONE NA INC. VACUETTE TUBE 2 ML Z NO ADDITIVE 13X75 BLACK CAP-YELLOW RING, NON-RIDGED; BLOOD COLLECTION TUBES

Model Number 454318H, 454318

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Gbo complaint number: (b)(4).We have no further complaints on the material/batch.We have no further inventory of the material/batch.We are waiting for customer to return samples for evaluation.We will file supplement report if we receive samples and have investigation report.

Event Description

Customer states there are particulates in the tubes.

Manufacturer Narrative

Gbo complaint number: (b)(4).No samples were received for evaluation.We have no further complaints on the materials / batches.We have no further inventory of the materials / batches.A check of quality, production, and maintenance documents revealed no deviations in relation to the reported event.Therefore, the complaint cannot be determined.

Event Description

Customer states there are particulates in the tubes.

• Brand Name: VACUETTE TUBE 2 ML Z NO ADDITIVE 13X75 BLACK CAP-YELLOW RING, NON-RIDGED
• Type of Device: BLOOD COLLECTION TUBES
• Manufacturer (Section D): GREINER BIO-ONE NA INC.; 4238 capital drive; monroe NC 28110
• MDR Report Key: 10803539
• MDR Text Key: 225950118
• Report Number: 1125230-2020-00044
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: BK050026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2021
• Device Model Number: 454318H, 454318
• Device Catalogue Number: 454318H, 454318
• Device Lot Number: B200738P, B20073XN, B20033BB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1