MAUDE Adverse Event Report: GREINER BIO-ONE GMBH VACUETTE QUICKSHIELD COMPLETE PLUS 21GX1'' SP; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number 450235

Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Gbo complaint: (b)(4).No samples were received.Actual samples were not returned for evaluation.No pictures of the actual samples were received.We have no further inventory of the material/batch.We forwarding the complaint to our affiliated headquarters in (b)(4) from which we receive this product.According to their investigation and comments, a review of the production and testing documents indicate no deviations were detected and all requirements were met during production.No abnormalities or deficiencies were detected during in process control that would affect function.Documents for the batch final checking, which includes functional testing, indicate no abnormalities.During production the product is tested during in process control and final checking.The complaint can not be determined.

Event Description

Customer states that on four occasions the needle came out of the holder and stuck in the arm of the patients when tubes were inserted in to the holder, as if the needles are not firmly attached.No injuries to patients occurred as a result, nor did any blood exposures or needle stick injuries occur to any employees.

• Brand Name: VACUETTE QUICKSHIELD COMPLETE PLUS 21GX1'' SP
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): GREINER BIO-ONE GMBH; bad haller strasse 32; kremsmuenster, oberosterreich, A-455 0; AU A-4550
• Manufacturer (Section G): GREINER BIO-ONE NA INC; 4238 capital drive; monroe, nc
• Manufacturer Contact: manfred abel ; 4238 capital drive; monroe, nc ; 2617800782
• MDR Report Key: 10448728
• MDR Text Key: 207552443
• Report Number: 8020040-2015-00027
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: 450235
• Device Catalogue Number: 450235
• Device Lot Number: G150233C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2015
• Initial Date FDA Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2018
• 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