MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381034

Device Problem Contamination (1120)

Patient Problems Unspecified Infection (1930); Septic Shock (2068)

Event Date 10/10/2017

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.Initial reporter phone#: (b)(6).Device manufacture date: unknown.Investigation: investigation summary: as no sample nor lot number were provided, confirmation of the defect stated in the reported issue could not be identified or confirmed.Investigation conclusion: units were not received for observation and testing.The defect of infection, stated in the description of the complaint could not be identified or confirmed and cause could not be determined, as the units described in the product incident report were not returned for evaluation and testing.Therefore, there was no physical evidence to confirm or to support manufacturing process related issues for the reported defect.Unable to confirm the customer¿s experience because units were not returned for evaluation and testing.Root cause description: without the actual sample for evaluation and testing there was no physical evidence to confirm or support manufacturing process related issues for the reported defect.

Event Description

It was reported that an infection occurred at the puncture site after inserting a bd insyte¿ autoguard¿ bc shielded iv catheter.Patient experienced septic shock and was hospitalized in the icu.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7061015
• MDR Text Key: 92997900
• Report Number: 1710034-2017-00413
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/10/2017

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?: No
• Device Operator: Other
• Device Catalogue Number: 381034
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2017
• Initial Date FDA Received: 11/27/2017
• 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): Hospitalization; Required Intervention