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

Catalog Number 360213

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem Exposure to Body Fluids (1745)

Event Date 01/22/2024

Event Type  Injury  

Manufacturer Narrative

B3: date of event is unknown.The date received by manufacturer has been used for this field.E1: initial reporter phone #: (b)(6).H3: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd vacutainer® precisionglide¿ multiple sample needle, there were two instances of sleeve leakage.The health professional was exposed to blood and was not wearing ppe.Patient's blood was not infectious, and the health professional did not receive any treatment.

Event Description

It was reported that while using bd vacutainer® precisionglide¿ multiple sample needle, there were two instances of sleeve leakage.The health professional was exposed to blood and was not wearing ppe.Patient's blood was not infectious, and the health professional did not receive any treatment.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for evaluation: yes.D.9:device eval by manufacturer? yes.D9: returned to manufacturer on: 2024-february -15th.H.6 investigation summary: material #: 360213.Lot/batch #: 3067041.Bd received 400 samples for investigation.Ten (10) of the samples were evaluated by functional testing, each used to draw 6 vacutainer tubes, and the indicated failure mode for sleeve leakage with the incident lot was not observed as all product specifications were met.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 issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode sleeve leakage.Bd was not able to identify a root cause for the indicated failure mode.

• Brand Name: BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE
• Type of Device: BLOOD COLLECTION NEEDLE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18669062
• MDR Text Key: 334951579
• Report Number: 9617032-2024-00156
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 30382903602132
• UDI-Public: (01)30382903602132
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 360213
• Device Lot Number: 3067041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2024
• Supplement Dates Manufacturer Received: 02/16/2024
• Supplement Dates FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2023
• 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
• Patient Outcome(s): Other