MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INTRODUCER INTROSYTE-N; INTRODUCER, CATHETER

Catalog Number	384021
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd introsyte-n precision intro sheath tab broke.The following information was provided by the initial reporter: did this event reach the patient? no.Other insertion site issue tearaway sheath broke off.Bd introsyte-n introducer used for 1.9fr picc insertion.Once picc was placed and it was time to remove the introducer the rn pulled the purple tabs of the tearaway sheath.Instead of the tearaway breaking in half and pulling easily away, part of the tab broke off the tearaway sheath leaving the sheath wrapped around the picc.Forceps were needed to grasp the tearaway sheath to remove from the picc line.
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
No additional information.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 1 photo and 1 physical sample submitted for evaluation.The reported issue of introducer defective / damaged was confirmed upon inspection of the samples.Analysis of the sample showed that the reported defect can be observed.The sheath are supplied to us by a third-party supplier, and they have been made aware of this issue.Production records were reviewed, and this batch meets our manufacturing specification requirements.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD INTRODUCER INTROSYTE-N
• Common Device Name: INTRODUCER, CATHETER
• 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: 22703446
• Report Number: 1710034-2025-01282
• Device Sequence Number: 18362505
• Product Code: DYB
• UDI-Device Identifier: 50382903840217
• UDI-Public: (01)50382903840217(17)271130(10)4355428
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K020834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2025

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: 4355428
• 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: 07/17/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 10/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown