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

Catalog Number	381012
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that bd.The following information was provided by the initial reporter: as the clinical nurse educator for bd i was observing some cannulations.We had received complaints that the 24-gauge cannula was not advancing properly and that at times the needle was not retracting.Myself and the iv nurse specialist observed 10 cannulas being inserted and there was no obvious sign of this issue.One of the nursing staff asked if she could try on the vein board i had with me.It was very obvious that the cannula was difficult to thread off.I observed the nurse turning the cannula to loosen it prior to insertion however it was very stiff.The nurse informed me that this is happening frequently.It is difficult for the nursing staff to retain the product as they are still managing to get the cannula into the patient however not with the same ease.Additionally, they are having some cannulas that the needle is not retracting.I have asked the staff to keep any cannulas that they are having issues with and that they will be able to send back.
Additional Manufacturer Narrative
The complaint of complications during the insertion procedure could not be confirmed from the 24g insyte autoguard device that was returned for investigation.A visual and microscopic examination revealed no damage or defects that would have contributed to the reported issue.A functional test revealed that the needle fully retracted within the safety shield and the retraction time was within specification.The tip of the iv catheter was acceptable according to the visual standard.Although the 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.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.

• Brand Name: BD INSYTE AUTOG BC GLOBAL
• Common Device Name: 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: 22340637
• Report Number: 1710034-2025-01091
• Device Sequence Number: 9069436
• Product Code: FOZ
• UDI-Device Identifier: 00382903810123
• UDI-Public: (01)00382903810123(11)250225(17)280131(10)5051387
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 381012
• Device Lot Number: 5051387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown