MAUDE Adverse Event Report: GREINER BIO-ONE NA INC. VACUETTE BLOOD COLLECTION TUBES EDTA; EVACUATED BLOOD COLLECTION TUBES

Model Number 454209

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

(b)(6): no date of the event could be obtained from the customer.Recently samples were received from the customer for evaluation.As soon as the investigation is completed, a supplemental report will be filed.

Event Description

Customer states increased amount of clotted lavender tubes.Direct observations and training have been done regarding proper tube inversions.There have been 3 occurrences.Clotting does not occur when a particular device is used for collection.The tubes are inverted the recommended number of times as per ifu.The tubes are properly filled to +/-10% of fill mark.No photos are available.1 tube available to return of lot b210834x.I will request the customer return this tube.Lot b21093gk no tubes available to return at this time.

Manufacturer Narrative

Received 1pc.454209/b210834x for evaluation.We have no further complaints on the material/batches.A check of quality, production, and maintenance records revealed no deviations in relation to the reported event.Customer sample was tested, according to gbo standard testing procedures, with regards to correct assembly, draw volume and additive content according to iso 6710 'single use containers for venous blood specimen collection' and clsi gp39-a6 regulations for 'evacuated tubes and additives for blood specimen collection'.Tube was verified to be correctly assembled.Both standards specify the draw volume to be within +/- 10% range of the nominal fill volume.No visual deviation in fill volume, sporadic low or high fill, could be observed in the tested sample.The tube tested filled within the +/-10% tolerance range.Additive content was found to be within specification in tested sample.No deviations could be duplicated in the customer returned sample.

• Brand Name: VACUETTE BLOOD COLLECTION TUBES EDTA
• Type of Device: EVACUATED BLOOD COLLECTION TUBES
• 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: 12864177
• MDR Text Key: 288137704
• Report Number: 1125230-2021-00087
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042927
• 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: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2022
• Device Model Number: 454209
• Device Catalogue Number: 454209
• Device Lot Number: B210834X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2021
• 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