MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/29/2020

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that catheter and hub separated while inserted and broke off in patients vein with a unspecified bd insyte¿ autoguard¿ shielded iv catheter.The following information was provided by the initial reporter: (1 of 2 complaints) it was reported the catheter and hub became separated while inserted in patient.Additional information received from customer: power injector reached max pressure on injection but enhancement was adequate for image acquisition.Post scan iv catheter noted to have broken off in patient's vein.Ed provider and rn called to ct.Ed physician removed catheter with no known complication.

Manufacturer Narrative

H.6.Investigation summary : bd received one photograph which displayed the catheter appearing separated from the rest of the unit.The reported issue was confirmed.This type of failure is likely to be a manufacturing process related issue.The failure mode of ¿catheter wedge back out¿ could potentially be caused by incorrect swage depth or incorrect flare length.Measurements could not be performed without the actual sample; and the photo did not provide sufficient details to identify any molding defects that may potentially affect the swaging process.A device history review could not be completed as no batch number was provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see section h.10.

Event Description

It was reported that catheter and hub separated while inserted and broke off in patients vein with a unspecified bd insyte¿ autoguard¿ shielded iv catheter.The following information was provided by the initial reporter: (1 of 2 complaints) it was reported the catheter and hub became separated while inserted in patient.Additional information received from customer: power injector reached max pressure on injection but enhancement was adequate for image acquisition.Post scan iv catheter noted to have broken off in patient's vein.Ed provider and rn called to ct.Ed physician removed catheter with no known complication.

• Brand Name: UNSPECIFIED BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9733353
• MDR Text Key: 188336631
• Report Number: 2243072-2020-00250
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 01/31/2020
• Initial Date FDA Received: 02/20/2020
• Supplement Dates Manufacturer Received: 01/31/2020
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other