MAUDE Adverse Event Report: GREINER BIO-ONE NA INC VACUETTE TUBE 3.5 ML LH LITHIUM HEPARIN SEPARATOR 13X75 GREEN CAP-YELLOW RING,; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 454008P

Device Problem Decrease in Suction (1146)

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

Event Type  malfunction  

Manufacturer Narrative

Gbo complaint: (b)(4).No samples were provided by the customer.Received customer pictures and case detail report.We have no further complaints on the material/batches.We have no further inventory of the material/batches.A review of quality, production and maintenance records revealed no deviation.Unfortunately, without customer samples, a proper investigation cannot be conducted.The complaint cannot be determine.

Event Description

Customer states tubes are losing vacuum.The tube failing is causing patients to have to be recollected.It is an inconvenience to their patients who need to come back in to have blood drawn multiple times for same test.For occurrences of tubes losing vacuum, customer advises that they were having more than 5 tubes a day.The laboratory staff is trained and signed off on how to collect tubes.They have been observed on applying proper pressure to the tubes during collection.If they reinsert the tube into the holder, more times than not they get blood return and are able to fill up the tubes properly.For blood collection, they are using bd straight 22g eclipse needles or vacuette safety blood collection sets with lauer adapter.If a safety blood collection set is used, a waste tube is drawn.This is occurring with phlebotomists as well as other departments as they start ivs for patients.

• Brand Name: VACUETTE TUBE 3.5 ML LH LITHIUM HEPARIN SEPARATOR 13X75 GREEN CAP-YELLOW RING,
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• 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: 10568377
• MDR Text Key: 210628446
• Report Number: 1125230-2020-00022
• 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: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2021
• Device Model Number: 454008P
• Device Catalogue Number: 454008P
• Device Lot Number: B200339C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1