MAUDE Adverse Event Report: GREINER BIO-ONE GMBH HOLDEX SINGLE-USE HOLDER PP SINGLE PACKED, STERILE WITH LID ON THE INNER PACK; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	450263DE
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).Holdex single use holdex.No decision tree available because medical device reporting was done based on authorities request.The holder filled with blood.
Event or Problem Description
During the use of 450263de problems in regards to blood collection were observed.No blood flow during collection procedure and leakage.

• Brand Name: HOLDEX SINGLE-USE HOLDER PP SINGLE PACKED, STERILE WITH LID ON THE INNER PACK
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): GREINER BIO-ONE GMBH; greiner bio-one gmbh; kremsmuenster,, 4550 ; AU 4550
• MDR Report Key: 9745902
• Report Number: 8020040-2017-00011
• Device Sequence Number: 1802423
• Product Code: FMI
• UDI-Device Identifier: 29120017577588
• UDI-Public: 29120017577588
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• 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 Expiration Date: 09/23/2019
• Device Model Number: 450263DE
• Device Catalogue Number: 450263DE
• Device Lot Number: A16103P4
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2017
• Initial Report FDA Received Date: 02/24/2020
• 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