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

Catalog Number 381034

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction, Injection Site (2442)

Event Date 07/31/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Date received by manufacturer: bd was initially made aware of this complaint on 2020-06-22.At that time, based on the information provided by the initial reporter, it was evaluated as a non-reportable incident.Additional information was later received on 2020-07-31 that changed the reportability determination.Based on the additional information received, this complaint is now considered to be an mdr reportable incident.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that 5 patients suffered "veinitis" when the bd insyte¿ autoguard¿ bc shielded iv catheters were used on them.This caused a delay of treatment/prolonged hospitalization, changing of pvc, and administration of fusidine antibiotics.One patient also received an additional ofloxacine antibiotic treatment.The following information was provided by the initial reporter, translated from french to english: "for one week we have observed the presence of veinitis in 5 patients.Peripheral venous catheter (pvc) passed in gastroenterology and nefrology departement, in emergency departement.After investigation in gastroenterology and nefrology departement, 4 time protocol respected by the nurses, the recommended time of use wasn't exceeded." "delay in patient care or prolongation of hospitalization changing of pvc administration of fusidine (antibiotics), fusidine is a prescription drug in the form of a cream or ointment, it is used to treat skin infections.One patient needed an antibiotic treatment with ofloxacine.".

Manufacturer Narrative

H.6.Investigation: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.The complaint could not be confirmed and the root cause is undetermined.H3 other text : see h.10.

Event Description

It was reported that 5 patients suffered "veinitis" when the bd insyte¿ autoguard¿ bc shielded iv catheters were used on them.This caused a delay of treatment/prolonged hospitalization, changing of pvc, and administration of fusidine antibiotics.One patient also received an additional ofloxacine antibiotic treatment.The following information was provided by the initial reporter, translated from french to english: "for one week we have observed the presence of veinitis in 5 patients.Peripheral venous catheter (pvc) passed in gastroenterology and nefrology departement, in emergency departement.After investigation in gastroenterology and nefrology departement, 4 time protocol respected by the nurses, the recommended time of use wasn't exceeded." "delay in patient care or prolongation of hospitalization changing of pvc administration of fusidine (antibiotics), fusidine is a prescription drug in the form of a cream or ointment, it is used to treat skin infections.One patient needed an antibiotic treatment with ofloxacine.".

• 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
• MDR Report Key: 10463097
• MDR Text Key: 205504307
• Report Number: 1710034-2020-00542
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/31/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 381034
• Device Lot Number: 9330878
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/31/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 07/31/2020
• Supplement Dates FDA Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention