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

Catalog Number 381023

Device Problem Material Puncture/Hole (1504)

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

Event Date 02/28/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

It was reported that bd iag bc pro global needle pierced the catheter.The following information was provided by the initial reporter, translated from japanese to english: this is a complaint about the needle had poked through the catheter when the customer tried to use it.

Manufacturer Narrative

Investigation results: the complaint that the needle had poked through the catheter could not be confirmed from the photographs and 22g insyte autoguard that were provided for investigation.A microscopic and functional test of the returned sample revealed no damage or defects.The reported issue was not identified on the photographs.Although the photos, returned sample, and manufacturing records 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.

Event Description

No additional information.

• Brand Name: BD IAG BC PRO GLOBAL
• 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: 18983436
• MDR Text Key: 338767248
• Report Number: 1710034-2024-00242
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903810239
• UDI-Public: (01)00382903810239
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

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: 381023
• Device Lot Number: 3172364
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1