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

Model Number	392523
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the catheter was sheared with a bd insyte¿ autoguard¿ bc pro shielded iv catheter.The following information was provided by the initial reporter "it was reported that the catheter sheared.".
Additional Manufacturer Narrative
H6: investigation summary: our quality engineer inspected the photograph provided for evaluation.Bd received one photo of a 22ga x 1.00in.Insyte autoguard bc pro unit.Through the visual inspection, the needle is visible piercing through the catheter.Media is present indicating that the device had been used.During manufacturing this may occur due to alignment of the set together station, bent tubing, or air blow inconsistency.There is a 100% vision system inspection and a sampling plan implemented for lie distance, which mitigates the occurrence of this defect.In the user environment, during tip adhesion break it is possible for the needle to spear through the catheter.Based on the provided photo the catheter is slid up the cannula.It is also possible that while sliding the catheter back and forth the needle can pierce through the cannula.Since this defect is in the middle of the catheter with the catheter slid up the needle and with media present, this was more than likely caused in the user environment.
Event or Problem Description
It was reported that the catheter was sheared with a bd insyte¿ autoguard¿ bc pro shielded iv catheter.The following information was provided by the initial reporter "it was reported that the catheter sheared.".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC PRO 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: 15254828
• Report Number: 1710034-2022-00444
• Device Sequence Number: 6635982
• Product Code: FOZ
• UDI-Device Identifier: 00382903925230
• UDI-Public: 00382903925230
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2022

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 Model Number: 392523
• Device Catalogue Number: 392523
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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