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

Catalog Number 202-0005

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

Patient Problem Insufficient Information (4580)

Event Date 12/15/2023

Event Type  Injury  

Event Description

It was reported that bd pivo blood collection had patient who was diagnosed with an infection.The following information was provided by the initial reporter: representatives of (b)(6) network have made verbal comments with concerns of increased infections in patients: material 2: 202-0005 lot: 092322-02.

Manufacturer Narrative

Batch # 092322-02 was provided for this reported material number.It is not a valid lot 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.

Manufacturer Narrative

Grid update as lot 092322-02 is valid for pivo product.The reported defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.H3 other text : see narrative.

• 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: 18499893
• MDR Text Key: 332723962
• Report Number: 1710034-2024-00008
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 10850984007024
• UDI-Public: (01)10850984007024
• 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: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

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: 202-0005
• Device Lot Number: 092322-02
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other