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

Model Number	381437
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter needle puncture through the catheter.  the following information was provided by the initial reporter: i received another iv catheter with a similar issue.This issue was noticed after use.No harm to the patient that we're aware of.
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter needle puncture through the catheter.  the following information was provided by the initial reporter: i received another iv catheter with a similar issue.This issue was noticed after use.No harm to the patient that we're aware of.
Additional Manufacturer Narrative
Investigation summary our quality engineer inspected the sample and photograph submitted for evaluation.Bd received one used 20g x 1.88in.Insyte autoguard unit from lot number 1300906.Additionally, one photo was received for investigation.The photo shows a view of the returned catheter with the needle piercing the catheter tubing.Blood residue can be seen inside the catheter tubing.The returned sample was received with the needle retracted.The catheter was microscopically inspected, and a v-shaped tear was found near the location shown in the photo.The reported defect of needle through catheter was confirmed.As blood residue was present in the unit, it is likely that the clinician attempted venipuncture with the returned unit.If the defect originated during the manufacturing process, the device would have been received by the customer with the needle piercing through the catheter tubing making a venipuncture attempt unlikely.Since venipuncture was attempted, it is likely that the defect originated in the clinician environment during use.A needle spear through may occur in the clinician setting during tip adhesion break or during venipuncture if the needle is advanced at a wrong angle or if the needle is moved up and down the catheter tubing.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Common Device Name: 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: 14602724
• Report Number: 1710034-2022-00287
• Device Sequence Number: 14721810
• Product Code: FOZ
• UDI-Device Identifier: 30382903814375
• UDI-Public: 30382903814375
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2022

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
• Operator of Device: Other
• Device Expiration Date: 10/31/2024
• Device Model Number: 381437
• Device Catalogue Number: 381437
• Device Lot Number: 1300906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown