MAUDE Adverse Event Report: GREINER BIO-ONE GMBH STANDARD TUBE HOLDER AND LUER ADAPTER; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	450209, 450070
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint number: (b)(4).A complaint was immediately made by our field service with the information about the affected products, the process and the effects created.The complaint was made in accordance with the regulations in our quality management systems.The affected batches were checked.No deviations were found.The incoming goods inspection of the affected luer adapter showed no abnormalities.The complaint evaluation showed no complaints relating to the luer, article 450070.As part of the complaint processing, the intended purpose was also included compared to the facts.The customer was informed that the use of the luer adapter in combination with intravenous cannulas from greiner bio-one is not provided.No decision tree available because medical device reporting was done based on authorities request.
Event or Problem Description
The beside mentioned medical devices of greiner bio-one were used together with a venflon from a different company during a blood collection procedure, which caused blood leakage at the luer connection.

• Brand Name: STANDARD TUBE HOLDER AND LUER ADAPTER
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): GREINER BIO-ONE GMBH; 32 bad haller strasse; kremsmuenster, 4550 ; AU 4550
• MDR Report Key: 9742229
• Report Number: 8020040-2017-00009
• Device Sequence Number: 13903756
• Product Code: FMI
• UDI-Device Identifier: 29120017577472
• UDI-Public: 29120017577472
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K974873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 450209, 450070
• Device Catalogue Number: 450209, 450070
• Device Lot Number: 16F16A, 16G28A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2017
• Initial Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention