MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INTROSYTE-N 26 GA (1.9F); CATHETER INTRODUCER

Model Number	384021
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter addr 1: (b)(6).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 the bd introsyte-n¿ 26 ga (1.9f) experienced a sheath that did not split as intended, and device damage while still considered operable.The following information was provided by the initial reporter: during the installation of an epicutaneo-caval catheter, the introducer, when the catheter is in place, did not come apart in two by the wings as it is normally designed.Clinical consequences: the treatment was prolonged by 20 minutes, the time to repair the pierced catheter.Conservative measures and actions taken: intervention of the doctor with forceps and scissors to remove the introducer which pierced the freshly placed catheter and caused a leak on this one.
Additional Manufacturer Narrative
H6: investigation: 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.The complaint could not be confirmed and the root cause is undetermined.
Event or Problem Description
It was reported that the bd introsyte-n¿ 26 ga (1.9f) experienced a sheath that did not split as intended, and device damage while still considered operable.The following information was provided by the initial reporter: during the installation of an epicutaneo-caval catheter, the introducer, when the catheter is in place, did not come apart in two by the wings as it is normally designed.Clinical consequences: the treatment was prolonged by 20 minutes, the time to repair the pierced catheter.Conservative measures and actions taken: intervention of the doctor with forceps and scissors to remove the introducer which pierced the freshly placed catheter and caused a leak on this one.

• Brand Name: BD INTROSYTE-N 26 GA (1.9F)
• Common Device Name: CATHETER INTRODUCER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 12346389
• Report Number: 1710034-2021-00728
• Device Sequence Number: 11746910
• Product Code: DYB
• UDI-Device Identifier: 50382903840217
• UDI-Public: 50382903840217
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K974764
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2021

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: 12/31/2023
• Device Model Number: 384021
• Device Catalogue Number: 384021
• Device Lot Number: 1005635
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1