MAUDE Adverse Event Report: GREINER BIO-ONE GMBH VACUETTE QUICKSHIELD COMPLETE PLUS 21G X 1.5"; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number 450239

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

Gbo complaint no: (b)(4).Received 1 box 450239/g150734e for evaluation.We have no further inventory of the material/batch.We have no further complaints on the material/batch.We forwarded the complaint and samples to our affiliated headquarters in (b)(6) from which we receive this product.According to their investigation and comments, a review of the production documentation indicates no deviations during the entire manufacturing process.No irregularities were detected during in process control.All requirements were met during production.There is a validated 100% check of the caps as well as an online control system checking fully assembled safety shields on the assembly line.In addition, during final checking, which includes functional and kickback tests, no abnormalities were observed.Samples were visually and functionally analyzed.No deviations were observed.The complaint cannot be confirmed.

Event Description

Customer states that they were encountering issues with needle caps being loose and coming off of the needles upon opening, safety shields being loose when trying to activate the safety and tube kickback (tubes violently popping off / flying across the room).No injuries / blood exposures have occured as a result.

• Brand Name: VACUETTE QUICKSHIELD COMPLETE PLUS 21G X 1.5"
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): GREINER BIO-ONE GMBH; bad haller strasse 32,; kremsmuenster oberosterreich,, AT A -455; AU AT A-4550
• Manufacturer (Section G): GREINER BIO-ONE NA INC; 4238 capital drive; monroe NC 28110
• Manufacturer Contact: manfred abel ; 4238 capital drive; monroe, NC 28110 ; 7042617823
• MDR Report Key: 10635064
• MDR Text Key: 214805522
• Report Number: 8020040-2016-00023
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2018
• Device Model Number: 450239
• Device Catalogue Number: 450239
• Device Lot Number: G150734E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2016
• 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