MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA; INTRAVASCULAR CATHETER

Catalog Number 309659

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/19/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 22ga foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: some of the syringes have had what looks like a residue in the very tip.We took a q-tip to the tip of the syringe and it didn't appear that anything came off on it, so we are thinking it is just part of the plastic, but the provider and nursing staff are wanting to confirm for safety purposes.".

Manufacturer Narrative

Investigation summary: two photos were provided to our quality team for investigation.Through visual inspection, it was observed that a small amount of plastic extending out of the tip of the barrel.The reported defect could not be verified from the photos received.A physical sample is required for a more thorough evaluation and potential root cause determination.A device history record review was completed for provided lot number 2284476.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.

Event Description

It was reported while using bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 22ga foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: some of the syringes have had what looks like a residue in the very tip.We took a q-tip to the tip of the syringe and it didn't appear that anything came off on it, so we are thinking it is just part of the plastic, but the provider and nursing staff are wanting to confirm for safety purposes.".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA
• 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: 16120557
• MDR Text Key: 308712258
• Report Number: 1710034-2022-00904
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903810239
• UDI-Public: (01)00382903810239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• 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: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309659
• Device Lot Number: 2284476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 01/09/2023
• Supplement Dates Manufacturer Received: 02/09/2023
• Supplement Dates FDA Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2022
• 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