MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE-N AUTOGUARD WINGED; PERIPHERAL IV CATHETERS

Catalog Number	381911
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/17/2024
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 insyte-n autoguard winged split/divides.The following information was provided by the initial reporter, translated from french to english: the cathlon splits and divides when the child is pricked children infused multiple times because cathlons fail, pain.
Additional Manufacturer Narrative
Investigation results: a device history record review was completed by our quality engineer team for provided material number 381911 and lot number 3180656.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.
Event or Problem Description
Could you please tell did the catheter broke and or separate or did the catheter split while inserted possibly due to the needle piercing through the catheter wall.If a piece of the catheter was separated, did this remain in the patient? was it retrieved? "the catheter was not visually split during the pre-placement check-up.When we prick the patient, the passage of the initial skin is easy but as soon as about 2mm is inserted, a great resistance is felt, an intense pain for the patient.Immediate removal of the catheter is necessary.When it is removed, we notice that the cathlon is separated in two at the end like a fork.We don't think a piece came off.This inconvenience has been quite common in recent weeks with these yellow cathlons.".

• Brand Name: BD INSYTE-N AUTOGUARD WINGED
• 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: 19574945
• Report Number: 1710034-2024-00625
• Device Sequence Number: 3943771
• Product Code: FOZ
• UDI-Device Identifier: 00382903819119
• UDI-Public: (01)00382903819119
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: 381911
• Device Lot Number: 3180656
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown