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

Catalog Number	382957
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	06/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.It is unclear if a serious injury occurred as there was no confirmation of retained object.Filing conservatively as an si.
Event or Problem Description
It was reported that bd insyte autog bc global wing catheter broke.The following information was provided by the initial reporter: g16 was introduced to patient skin during initial insertion.Upon slow retraction of the cannula, noticed that half of the cannula was gone.Very minimal blood-tinged was on the insertion site.Cannula kept aside.Second cannula, g18 was inserted on the right ej vein with good backflow, secured accordingly.Xray done on the right neck, seen by icu dr and called gs.At 0150h, gs came to assess the patient, xray showed by icu dr.At 0100h, repeat xray for the right neck was done by tech.No new orders made by gs nor icu dr.Charge nurse aware.Cannula kept aside.(cannula-bd insyte autoguardbc pro winged g.16).
Event or Problem Description
No new information.
Additional Manufacturer Narrative
The complaint of a damaged device or complications during use could not be confirmed from the two representative 16g insyte autoguard devices that were received in sealed unit packages from lot # 3364227.A visual and microscopic examination revealed no damage or defects that would contribute to the reported issue.Although the representative samples 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.
Event or Problem Description
Additional information: questions: it appears that x-rays were done to rule out a retained catheter.What were the results of the x-ray? did the patient require any further treatment specifically related to this reported event? customer response: as i understood a part of the catheter remained in the patient and had to be indeed surgically remove (the catheter not the needle) hence i believe the x-ray part of the report.During our meeting, he did not mention specifically x-ray; it might have been mentioned in the first report that was drafted (which for me was not clear enough to decipher).The physician also confirmed that the following day he had another catheter insertion for a different patient with no reported incidents.There are no additional comments or reports from the physician¿s / hospital ¿s side so far.
Additional Manufacturer Narrative
Additional information added to b tab patient e and f codes corrected.

• Brand Name: BD INSYTE AUTOG BC GLOBAL WING
• 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: 22394800
• Report Number: 1710034-2025-01128
• Device Sequence Number: 9061082
• Product Code: FOZ
• UDI-Device Identifier: 00382903829576
• UDI-Public: (01)00382903829576(11)240102(17)261231(10)3364227
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 382957
• Device Lot Number: 3364227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Supplement Date Received by Manufacturer: 08/19/2025; 09/24/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/19/2025; 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown