MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INTROSYTE-N 22 GA (2.8F); CATHETER INTRODUCER

Catalog Number	384031
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the bd introsyte-n¿ 22 ga (2.8f) experienced a broken/separated sheath.The following information was provided by the initial reporter: connector broke in the "butterfly".
Additional Manufacturer Narrative
H.6.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¿ 22 ga (2.8f) experienced a broken/separated sheath.The following information was provided by the initial reporter: connector broke in the "butterfly".

• Brand Name: BD INTROSYTE-N 22 GA (2.8F)
• Common Device Name: CATHETER INTRODUCER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 11159768
• Report Number: 1710034-2021-00020
• Device Sequence Number: 19762441
• Product Code: DYB
• UDI-Device Identifier: 00382903840311
• UDI-Public: 00382903840311
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K020834
• Number of Events Summarized: 1
• Summary Report (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): 02/18/2021

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: 09/30/2021
• Device Catalogue Number: 384031
• Device Lot Number: 8297875
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1