MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD IAG BC PRO GLOBAL WING; PERIPHERAL IV CATHETERS

Catalog Number 382923

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

E.Facility full name: (b)(6).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 bd iag bc pro global wing contained foreign matter on the catheter.The following information was provided by the initial reporter, translated from japanese to english: abnormal catheter tip, which looked like a "wisp", was removed.(= foreign body adhered?).Before puncturing the patient, the tip of the catheter looked like a "wisp" visually, but it was removed.(= foreign body adhered?).

Manufacturer Narrative

Investigation findings: the complaint of a burr or defect on the catheter could not be confirmed from the 22ga insyte autoguard unit or three photographs that were provided for investigation.A visual and microscopic observation could not confirm the reported issue.Although the sample and photos do not support the complainant¿s description of the reported event, the complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.Correction: additional information/ clarification of reported defect received.A burr on the catheter is not mdr reportable.

Event Description

What is meant by "wisp"? please describe.Wisp is translation of here.When the customer sees what looks like a burr on the catheter tip, the customer may say thank you.

• Brand Name: BD IAG BC PRO GLOBAL WING
• Type of Device: PERIPHERAL IV CATHETERS
• 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: 18278620
• MDR Text Key: 330116858
• Report Number: 1710034-2023-01401
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UKN
• 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,Followup
• Report Date: 01/19/2024

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: Health Professional
• Device Catalogue Number: 382923
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1