MAUDE Adverse Event Report: GREINER BIO-ONE NA INC. VACUETTE® TUBE 8 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 16X100; EVACUATED BLOOD COLLECTION TUBE

Model Number 455071P

Device Problem Filling Problem (1233)

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

Event Type  malfunction  

Event Description

Customer states that while switching tubes, they are hearing air and the tube was filling slower, almost like a balloon deflating noise.Customer advised after tube was centrifuged, the sample was hemolyzed.Per customer needle/bevel did not move when changing tubes.Customer is questioning if there is an issue with the sheathing covering the needle in the hub (holder).Customer stated: "they have heard feedback and experienced themselves the tubes popping off during a draw.

Manufacturer Narrative

Complaint (b)(4).A date of the event could not be obtained from the customer.Samples for evaluation were only recently received and are still under evaluation.As soon as the investigation of the event is completed, a supplemental report will be filed.

Manufacturer Narrative

Complaint (b)(4).Received 2pcs 455071p/b220833p for evaluation.We have no further inventory of the material/batch.We have no further complaints for the material/batch.A check of quality, production and maintenance records revealed no deviations in relation to the reported errors.Customer samples were visually inspected, and no deviations were noted.Samples were then filled for additive testing.No kickback was observed.Additive content was found to be within specification in all tested samples.The alleged malfunction could not be duplicated on the returned samples.

• Brand Name: VACUETTE® TUBE 8 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 16X100
• Type of Device: EVACUATED BLOOD COLLECTION TUBE
• Manufacturer (Section D): GREINER BIO-ONE NA INC.; 4238 capital drive; monroe NC 28110
• Manufacturer (Section G): GREINER BIO-ONE NA INC.; 4238 capital drive; monroe NC 28110
• Manufacturer Contact: manfred abel ; 4238 capital drive; monroe, NC 28110 ; 7042617823
• MDR Report Key: 15859079
• MDR Text Key: 305682580
• Report Number: 1125230-2022-00048
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960858
• 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,Followup
• Report Date: 12/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 455071P
• Device Catalogue Number: 455071P
• Device Lot Number: B220833P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1