MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. INTROSYTE-N; INTRODUCER, CATHETER

Catalog Number	384021
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was provided by the initial reporter (case 2): i am a nurse practioner at xxxx.I need to report a problem with your introsyte-n precision introducers.Ref number 384021.Lot number 4346753.I have had two separate occasions with two separate patients where the wing breaks off before the sheath is peeled away leaving the catheter trapped inside.This is not a case of lack of experience.I have been inserting picc lines for 25 years.Xxx customer response on 20-aug-2025.The first event happened on (b)(6) 2025.No harm to the patient.The second event happened on (b)(6) 2025.No harm to the patient.I was told that the defective introducers, along with the unused introducers with the same lot number, were returned to the company by (b)(6).In both cases the catheter was in place and the wing broke off while attempting to peel the introducer back to remove it.It was very difficult to remove the introducer without dislodging the catheter or damaging the catheter.
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.E1.Address information was not provided; therefore, (b)(6) was used as the state.
Additional Manufacturer Narrative
Investigation results: a device history record review was completed by our quality engineer team for provided material number 384021 and lot number 4346753.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.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: INTROSYTE-N
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22916533
• Report Number: 9610847-2025-00283
• Device Sequence Number: 9755058
• Product Code: DYB
• UDI-Device Identifier: 50382903840217
• UDI-Public: (01)50382903840217
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K020834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2025

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: 384021
• Device Lot Number: 4346753
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown