MAUDE Adverse Event Report: GREINER BIO-ONE NA INC VACUETTE 4ML LH LITHIUM HEPARIN SEPARATOR 13X75; BLOOD COLLECTION TUBES

Model Number 454008P

Device Problems High Readings (2459); Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

Gbo complaint no: (b)(4).Received 1rk 454008p/b16063fs for evaluation.We have no further inventory of the material/batch.Samples were tested and tubes were verified to be correctly assembled and had the correct fill guide line position.Additive content was found to be within specification in all tested samples.Samples were checked for potassium content and none could be detected.Samples have been evaluated in a blood draw.Gel barriers formed correctly and good separation was observed in all tested samples when centrifuging using recommended parameters within 2 hours.The appearance of the gel barriers (minor rbcs within) is similar to those in previous blood draws.No hemolysis as described by the customer was observed.No rbcs in plasma as described by the customer were observed.No customer pictures were provided for comparison.No deviations could be observed on the samples.The complaint cannot be confirmed.

Event Description

Customer states: elevated potassium/repeat's are normal/after centrifuging at times the plasma has a reddish color and the blood appears to seep through the gel.It has been reported from our processing lab rbc are present in the plasma.

• Brand Name: VACUETTE 4ML LH LITHIUM HEPARIN SEPARATOR 13X75
• Type of Device: 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 ; 7042617800
• MDR Report Key: 10719398
• MDR Text Key: 215070231
• Report Number: 1125230-2016-00014
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2017
• Device Model Number: 454008P
• Device Catalogue Number: 454008P
• Device Lot Number: B16063FS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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