MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER PRECISIONGLIDE MULTIPLE SAMPLE NEEDLE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	360211
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Fda device problem code(s): 1354, ] fda patient problem code(s): 2199.
Event or Problem Description
It was reported the bd vacutainer® precisionglide¿ multiple sample needle experienced tube push off non-patient end needle.The following information was provided by the initial reporter.The customer stated: "when we push the tube into the holder and it is pierced by the needle (blood flows into the tube), we must absolutely keep the tube pressed with your thumb.If we don't, the tube pops out of the needle and holder in a totally random fashion.".
Event or Problem Description
It was reported the bd vacutainer® precisionglide¿ multiple sample needle experienced tube push off non-patient end needle.The following information was provided by the initial reporter.The customer stated: "when we push the tube into the holder and it is pierced by the needle (blood flows into the tube), we must absolutely keep the tube pressed with your thumb.If we don't, the tube pops out of the needle and holder in a totally random fashion.".
Additional Manufacturer Narrative
Investigation summary : 10 retention samples from bd inventory were evaluated by functional testing and the issue of tube push off was not observed.This type of defect may occur due to the resilience of the sleeve and / or the level of lubrication of the np needle.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality non-conformance's during manufacturing of the product.

• Brand Name: BD VACUTAINER PRECISIONGLIDE MULTIPLE SAMPLE NEEDLE
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• MDR Report Key: 10977500
• Report Number: 9617032-2020-01022
• Device Sequence Number: 830181
• Product Code: JKA
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2021

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
• Operator of Device: Other
• Device Expiration Date: 01/31/2025
• Device Catalogue Number: 360211
• Device Lot Number: 0035829
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 01/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1