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

Catalog Number 381934

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

Patient Problems Bacterial Infection (1735); Pain (1994); Rash (2033)

Event Date 11/28/2021

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the patient developed lymphangitis sometime after the bd insyte¿ autoguard¿ shielded iv catheter was used on them, and had to have repeated dressing changes and perfusion.The following information was provided by the initial reporter, translated from french: "circumstances of occurrence: repeated lymphangitis on vvp cathlon // patient reperfused each time // change of maintenance bandages.Iv 3000 on 26/11 and 27/11 // tegaderm on 28/11.Clinical consequences observed: erythema and pain / risk of infection.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 12/28/2021.H.6.Investigation: our quality engineer inspected the sample submitted for evaluation.Bd received one catheter adapter assembly which was inspected for any defects that could cause an infection or irritation to the patient.A microscopic inspection of the catheter tip was performed and found to be within specification.The catheter tubing was also inspected for any defects and no abnormalities or defects were found.Finally, sterilization and lubrication records were reviewed and no quality issues or process deviations were found.Irritation or infection may also be affected by the sterility of the product in regard to package integrity and site sterility.Without the package for investigation, the package integrity could not be inspected.Additionally, site sterility can not be determined without being present during venipuncture.As the returned unit was found to be within specifications, bd was unable to confirm the reported defect.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.

Event Description

It was reported that the patient developed lymphangitis sometime after the bd insyte¿ autoguard¿ shielded iv catheter was used on them, and had to have repeated dressing changes and perfusion.The following information was provided by the initial reporter, translated from french: "circumstances of occurrence: repeated lymphangitis on vvp cathlon // patient reperfused each time // change of maintenance bandages.Iv 3000 on 26/11 and 27/11 // tegaderm on 28/11 clinical consequences observed: erythema and pain / risk of infection.".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13156620
• MDR Text Key: 284975318
• Report Number: 1710034-2021-01090
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

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 Expiration Date: 04/30/2024
• Device Catalogue Number: 381934
• Device Lot Number: 1117683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 01/04/2022
• Supplement Dates Manufacturer Received: 01/26/2022
• Supplement Dates FDA Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2021
• 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): Required Intervention