MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INTROSYTE-N¿; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

Model Number	384021
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while using the bd introsyte-n¿, the introducer did not split properly and was broken.The following information was provided by the initial reporter, translated from (b)(6): bd introsyte-n introducer did not peel properly upon removal.It even broke trying to break it, which pierced the ktecc in place.In addition, a small piece of the introducer broke.
Additional Manufacturer Narrative
H.6.Investigation: since no photos or samples displaying the reported conditions of peel incorrect / will not peel and introducer defective / damaged 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.The complaint could not be confirmed and the root cause is undetermined.
Event or Problem Description
It was reported that while using the bd introsyte-n¿, the introducer did not split properly and was broken.The following information was provided by the initial reporter, translated from french: bd introsyte-n introducer did not peel properly upon removal.It even broke trying to break it, which pierced the ktecc in place.In addition, a small piece of the introducer broke.

• Brand Name: BD INTROSYTE-N¿
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14046062
• Report Number: 1710034-2022-00176
• Device Sequence Number: 4907685
• Product Code: FOZ
• UDI-Device Identifier: 50382903840217
• UDI-Public: 50382903840217
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2022

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: 07/31/2024
• Device Model Number: 384021
• Device Catalogue Number: 384021
• Device Lot Number: 1216414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2022
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 05/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown