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

Catalog Number	384021
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.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 the defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.
Event or Problem Description
It was reported that while using the bd introsyte-n¿ introducer the sheath did not split as intended.The following information was provided by the initial reporter, translated from portuguese to english: after inserting the picc catheter the introducer did not open to remove it.

• Brand Name: BD INTROSYTE-N INTRODUCER
• Common Device Name: CATHETER INTRODUCER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 12211154
• Report Number: 1710034-2021-00601
• Device Sequence Number: 4412267
• Product Code: DYB
• UDI-Device Identifier: 00382903840212
• UDI-Public: 00382903840212
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K020834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2021

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: Other
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 384021
• Device Lot Number: 9151825
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1