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

Catalog Number 384021

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

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¿ 26 ga (1.9f) experienced a broken/separated sheath.The following information was provided by the initial reporter: introducer did not break and ended up breaking the picc.

Manufacturer Narrative

H6: investigation summary: 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.H3 other text : see h.10.

Event Description

It was reported that the bd introsyte-n¿ 26 ga (1.9f) experienced a broken/separated sheath.The following information was provided by the initial reporter: introducer did not break and ended up breaking the picc.

• Brand Name: BD INTROSYTE-N 26 GA (1.9F)
• Type of Device: CATHETER INTRODUCER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 11103398
• MDR Text Key: 226099306
• Report Number: 1710034-2020-00851
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00382903840212
• UDI-Public: 00382903840212
• 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: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 384021
• Device Lot Number: 9084830
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1