MAUDE Adverse Event Report: GREINER BIO-ONE NA INC STANDARD TUBE HOLDER SHORT VERSION; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number 450209

Device Problem Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Manufacturer Narrative

Gbo complaint no: (b)(4).No samples (actual or unused) were received.Please advise the customer that we must have samples returned for quality assurance so that a proper investigation may be conducted.Customer uses bd needles and holders and only used greiner holders for a limited time while competitor was on backorder.No further information regarding the two incidents in the medwatch reports was received.We have no further inventory of the material/batch.We have no further complaints on the material/batch.We forwarded the complaint information to our affiliated headquarters in austria from which we receive this product.According to their investigation and comments, production documentation of this batch does not reveal any deviations regarding this error.There were no deviations regarding the screw-in torque in the concerned batches.

Event Description

Customer reported that a phlebotomist was drawing a patient's blood when the needle started to come loose from the holder.Phlebotomist was able to screw the needle back into the holder without injury to the patient.

• Brand Name: STANDARD TUBE HOLDER SHORT VERSION
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• 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: 10848087
• MDR Text Key: 225124644
• Report Number: 1125230-2017-00013
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 450209
• Device Catalogue Number: 450209
• Device Lot Number: B17063UP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2017
• 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: Initial
• Patient Sequence Number: 1