MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD PIVO BLOODCOLLECTON; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number 202-0006

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 12/15/2023

Event Type  Injury  

Manufacturer Narrative

D.Lot # 9453399 was provided, but it was not found in our system for the reported material number.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion a supplemental report will be filed.B3.The date received by manufacturer has been used for this field.

Event Description

It was reported that bd pivo blood collection used on patient who was diagnosed with an infection.The following information was provided by the initial reporter: representatives of (b)(6) have made verbal comments with concerns of increased infections in patients.Material 3: 201-0006, lot: 9453399.

• Brand Name: BD PIVO BLOODCOLLECTON
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18497532
• MDR Text Key: 332724838
• Report Number: 1710034-2024-00006
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00850984007034
• UDI-Public: (01)00850984007034
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190604
• 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: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 202-0006
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other