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

Catalog Number 382534

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/08/2022

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1351797.Medical device expiration date: 30-nov-2024.Device manufacture date: 17-dec-2021.Medical device lot #: 2053116.Medical device expiration date: 28-feb-2025.Device manufacture date: 22-feb-2022.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 an unspecified number of bd insyte¿ autoguard¿ bc shielded iv catheters experienced frayed catheters.The following information was provided by the initial reporter: sheering at the end of catheter is remaining in the patient.Several incidents this situation has happened.

Event Description

It was reported that an unspecified number of bd insyte¿ autoguard¿ bc shielded iv catheters experienced frayed catheters.The following information was provided by the initial reporter: sheering at the end of catheter is remaining in the patient.Several incidents this situation has happened.

Manufacturer Narrative

H6: investigation summary our quality engineer inspected the representative samples submitted for evaluation.Bd received 43 sealed 20g x 1.16in.Insyte autoguard bc units from lot number 2053116.All returned units were visually inspected for catheter damage and leak tested.The gross visual inspection did not identify any damage and leak testing did not identify any leaks.The returned units provided for evaluation met and performed per the required manufacturing specifications.There was no physical/mechanical evidence to confirm and support a manufacturing process related issue for the failures stated in the report.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15351257
• MDR Text Key: 305586651
• Report Number: 1710034-2022-00471
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903825349
• UDI-Public: 00382903825349
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 382534
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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