MAUDE Adverse Event Report: GREINER BIO-ONE GMBH VACUETTE QUICKSHILED COMPETE PLUS 22GX1.5", 21GX1.5"; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number 450228,450239

Device Problem Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Manufacturer Narrative

Gbo complaint: (b)(4).Received 1 box each for evaluation: 450228/g150233y, 450239/g1501908 and 450226/g150434y (non on original complaint).We forwarded the complaint and samples to our affiliated headquarter in (b)(6) 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 requirements were met during the production.No abnormalities or deficiencies were detected during process control that would affect function.Documents for the batch final checking, which includes functional testing, indicate no abnormalities.Samples were checked according to gbo standard testing procedures for damages, correct screwing in of needles and spin out of needles.The activation of the safety mechanism was checked according to the ifu.No damages or abnormalities that would affect function were experienced.Therefore the complaint could not be confirmed.

Event Description

Customer states that they are encountering issues with the shields on the devices being too loose, making activation of the safety difficult and unsafe.Customer feels that the shield on the most recent lots of the qscp rotational seem much looser than previous lots.No blood exposures or needle stick injuries have occurred as a result.

• Brand Name: VACUETTE QUICKSHILED COMPETE PLUS 22GX1.5", 21GX1.5"
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): GREINER BIO-ONE GMBH; bad haller strasse 32; kremsmuenster, oberosterreich, at 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: 10448823
• MDR Text Key: 206121049
• Report Number: 8020040-2015-00028
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: 450228,450239
• Device Catalogue Number: 450228,450239
• Device Lot Number: G150233Y, G1501908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2015
• Initial Date FDA Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2015
• 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