MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOG BC; PERIPHERAL IV CATHETERS

Catalog Number 382534

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.If additional information becomes available, a supplemental report will be filed.E4.The initial reporter also notified the fda on (b)(6) 2023.Medwatch report is mw5146873.

Event Description

It was reported that bd insyte autog bc catheter broke during disengagement.The following information was provided by the initial reporter: while trying to place an iv the preop nurse met resistance.When inspecting the iv catheter, it was noted that the sheath over the catheter had broken.Pre op nurse obtained new iv catheter and placed it with no resistance.Catheter with broken sheath was given to unit leadership.Other pre-op nurse reported that this same problem happened to one of her patients the previous week.Per this rn (registered nurse), the previous iv went into the skin but then would not progress due to resistance, when rn tried to pull it back the nurse also met resistance.The nurse stated "i had to pull it back harder and when the catheter came out the sheath was broken and looked just like the one from today." the identification of the second patient is unknown to the team.All catheters with this lot number were removed from the unit.

• Brand Name: BD INSYTE AUTOG BC
• Type of Device: PERIPHERAL IV CATHETERS
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18185243
• MDR Text Key: 329900263
• Report Number: 1710034-2023-01330
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825340
• UDI-Public: (01)30382903825340
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 382534
• Device Lot Number: 3139597
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1