MAUDE Adverse Event Report: GREINER BIO-ONE GMBH VACUETTE QUICKSHIELD COMPLETE PLUS 22GX1" SP, 21GX1,5"; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number 450226, 450239

Device Problems Loose or Intermittent Connection (1371); Material Twisted/Bent (2981)

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

Event Type  malfunction  

Manufacturer Narrative

Gbo complaint no: (b)(4).Received 1 pc each: 450226/g1506354, 450239/g1510396 for evaluation.Neither sample was originally sealed (received already opened and activated).Received customer pictures.We forwarded the complaint, samples and pictures to our affiliated headquarters in (b)(4) from which we receive this product.According to their investigation and comments, a review of the production documentation indicates no deviations.No abnormalities occurred during in process control which includes functional testing.The returned samples were checked visually.No loose needles could be detected; one bent needle was detected.During the validated 100% in-process control for the threading in of the needle on the assembly line, the cap of the needle cannot be removed during the entire process.Therefore it is not possible for the needle to be bent during the production process.The complaint cannot be confirmed.

Event Description

Customer states that they are encountering issues with the needles being loose (unthreaded) and slightly bent upon opening.

• Brand Name: VACUETTE QUICKSHIELD COMPLETE PLUS 22GX1" SP, 21GX1,5"
• 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 28110
• Manufacturer Contact: manfred abel ; 4238 capital drive; monroe, NC 28110 ; 7042617800
• MDR Report Key: 10649959
• MDR Text Key: 219516474
• Report Number: 8020040-2016-00024
• 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: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2018
• Device Model Number: 450226, 450239
• Device Catalogue Number: 450226, 450239
• Device Lot Number: G1506354, G1510396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2016
• 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