MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE AUTOGUARD BC; PERIPHERAL IV CATHETERS

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Hemolysis (1886)

Event Date 04/02/2024

Event Type  malfunction  

Manufacturer Narrative

B.3.The date received by manufacturer has been used for this field.D.3.Franklin lakes has been listed as the manufacturer.Evaluation: as no physical sample, valid part number or lot number were provided for evaluation by our quality engineer team, a complete investigation could not be confirmed.Based on the limited investigation results, a cause for the reported incident could not be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

Event Description

Material # unknown.Batch # unknown.Hemolysis was reported during blood draw with the bd insyte autoguard bc.The following information was provided by the initial reporter: "hemolysis when drawing blood with insyte autoguard bc." verbatim: rcc received a complaint via email.Email(s) attached.Hemolysis when drawing blood with insyte autoguard bc.

• Brand Name: BD INSYTE AUTOGUARD BC
• Type of Device: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19194891
• MDR Text Key: 341594272
• Report Number: 2243072-2024-00572
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/05/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1