MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA 1.00IN; INTRAVASCULAR CATHETER

Model Number 381823

Device Problem Defective Component (2292)

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

Event Date 04/22/2022

Event Type  malfunction  

Event Description

It was reported while using bd insyte¿ autoguard¿ shielded iv catheter 22ga 1.00in the catheter was damaged.There was no report of patient impact.The following information was provided by the initial reporter: during the verification of the device and supplies, peripheral catheter no.22 with an open end ("flowery") was identified, three units were identified, of which two are kept, taken to quarantine.

Manufacturer Narrative

Patient¿s birthday was not provided, (b)(6) 1964 was used based on age of patient.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

Investigation summary our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph which displayed sufficient evidence to confirm the defect of needle through catheter.No other defects or abnormalities were found during the visual analysis of the photo.Although the reported issue was confirmed, it could not be determined if the damage resulted from the manufacturing of the device or from the user environment.Based on the evidence found during investigation, it cannot be confirmed with certainty if the defect originated during manufacturing or use since both scenarios are probable.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported while using bd insyte¿ autoguard¿ shielded iv catheter 22ga 1.00in the catheter was damaged.There was no report of patient impact.The following information was provided by the initial reporter: during the verification of the device and supplies, peripheral catheter no.22 with an open end ("flowery") was identified, three units were identified, of which two are kept, taken to quarantine.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA 1.00IN
• 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: 14548453
• MDR Text Key: 300923192
• Report Number: 1710034-2022-00274
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818235
• UDI-Public: 00382903818235
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 381823
• Device Catalogue Number: 381823
• Device Lot Number: 1183508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• 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 Age: 58 YR
• Patient Sex: Male