MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNSPECIFIED BD INSYTE AUTOGUARD BC PRO CATHETER

Catalog Number UNKNOWN

Device Problems Leak/Splash (1354); Retraction Problem (1536)

Patient Problems Bacterial Infection (1735); Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 04/13/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were 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 monthly. our business team regularly reviews the collected data for identification of emerging trends.Bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences. shall a sample or lot number become available, the complaint will be re-opened and an investigation will take place.

Event Description

It was reported that there was an infection while using unspecified bd¿ insyte autoguard bc pro catheter.There were also reports of leakage, needle retraction issues, and a needle stick injury after use.The following information was provided by the initial reporter: material no: unknown, batch no: unknown.It was reported via post market survey that the clinician encountered bloodstream infection (e.G.Blood stream bacteraemia, sepsis) (1), phlebitis (1), infiltration / extravasation (1), needlestick injury after use on patient after safety mechanism activation (1), catheter occlusion (1), and leakage (1).

• Brand Name: UNSPECIFIED BD INSYTE AUTOGUARD BC PRO CATHETER
• Type of Device: CATHETER
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11819310
• MDR Text Key: 250441399
• Report Number: 1710034-2021-00396
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other