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

Catalog Number 360213

Device Problem Fungus in Device Environment (2316)

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

Event Date 11/21/2023

Event Type  malfunction  

Event Description

It was reported that upon receiving bd vacutainer® precisionglide¿ multiple sample needle, the boxes and the needles were moldy.No patient impact reported.

Manufacturer Narrative

D4.Medical device expiration date: unknown h4.Device manufacture date: unknown d4.Medical device lot#: unknown b3: date of event is unknown.The date received by manufacturer has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted mfr report # 9617032-2024-00323 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore, this is not considered to be a reportable malfunction.Pictures were received on march 11th, 2024 that clearly show the outer shipment packaging was damaged with moisture.This was clearly evident to the customer when they received the shipment.There was no opportunity for the devices to be used.

Event Description

It was reported that upon receiving bd vacutainer® precisionglide¿ multiple sample needle, the boxes and the needles were moldy.No patient impact reported.

• 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: 18875462
• MDR Text Key: 337535088
• Report Number: 9617032-2024-00323
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 30382903602132
• UDI-Public: (01)30382903602132
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 03/13/2024

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: Other
• Device Catalogue Number: 360213
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 03/11/2024
• Supplement Dates Manufacturer Received: 03/11/2024
• Supplement Dates FDA Received: 03/13/2024
• 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