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

Catalog Number 384031

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 12/15/2020

Event Type  malfunction  

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 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".

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 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)
• Type of Device: CATHETER INTRODUCER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 11159768
• MDR Text Key: 227048048
• Report Number: 1710034-2021-00020
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00382903840311
• UDI-Public: 00382903840311
• Combination Product (y/n): N
• PMA/PMN Number: K020834
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 384031
• Device Lot Number: 8297875
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1