MAUDE Adverse Event Report: GREINER BIO-ONE GMBH URINE BEAKER WITH INTEGRATED TRANSFER DEVICE 100 ML, YELLOW LID SINGLE-PACKED; STERILE SAMPLE CONTAINER

Model Number 724310

Device Problems Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981)

Patient Problem Exposure to Body Fluids (1745)

Event Type  malfunction  

Manufacturer Narrative

Complaint (b)(4).A date of the event could not be obtained from the customer.Samples and more information was requested from the customer and will be forwarded to the affiliated headquarter, where we purchase this product from.As soon as the investigation is completed, a supplemental report will be filed.

Event Description

Customer states urine cups spray staff with urine upon collection of the sample (tube).In one incident a nurse got urine in her eye.The nurse was using the tubes to draw up urine from the cup as usual.The nurse does not recall which tube they started with.It was not a gray tube as the gray one often takes multiple attempts to work.(the gray tube is not from greiner].The first tube the nurse tried did not work as the needle dislodged and leaned sideways causing a vertical splash of droplets towards the nurse's face.At this point the needle was no longer attached to the urine cup.In another incident, a nurse got urine in her hair, eye and on her forehead.The nurse went to draw up urine from a urine collection device.When the nurse went to connect the yellow tube to the needle in the urine collection device, the needle immediately bent and urine shot straight into the air into the nurse's left eye, forehead, and hair.The customer is advising they do not know the lot of the cups involved and it is not available.They do not know the lot; therefore they are unable to return unused cups of the lot involved.They do have the 2 used cups involved in the incident.

Manufacturer Narrative

Received two used samples of 724310/unknown for evaluation.No unused samples were provided.Without unused samples a proper investigation cannot be conducted.Received customer picture.No batch number was provided.No further information was received.Unfortunately, without basic information, a thorough investigation is not possible.We forwarded the complaint and the used customer samples to our affiliated headquarters in austria from which we receive this product.Due to contamination risk, the used customer samples were unable to be evaluated.This complaint is closed as cannot be determined due to insufficient information.

• Brand Name: URINE BEAKER WITH INTEGRATED TRANSFER DEVICE 100 ML, YELLOW LID SINGLE-PACKED
• Type of Device: STERILE SAMPLE CONTAINER
• Manufacturer (Section D): GREINER BIO-ONE GMBH; bad haller str. 32; kremsmuenster, upper austria 4550 ; AU 4550
• MDR Report Key: 11569040
• MDR Text Key: 243728852
• Report Number: 8020040-2021-00015
• Device Sequence Number: 1
• Product Code: FMH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 724310
• Device Catalogue Number: 724310
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1