MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA¿ SAFETY IV CATHETER WITH WINGS AND BD MULTIGUARD¿ TECHNOLOGY; INTRAVASCULAR CATHETER

Model Number	386811
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 1 bd cathena¿ safety iv catheter with wings and bd multiguard¿ technology had needle through catheter while introducing the catheter issues.The following information was provided by the initial reporter translated from basque to english : "after the cannula does not advance, the due makes a small backward movement to recanalize and in the second advance there is resistance so decides to remove the cannula and finding at it's exit that the needle had perforated the catheter.".
Event or Problem Description
It was reported that 1 bd cathena¿ safety iv catheter with wings and bd multiguard¿ technology had needle through catheter while introducing the catheter issues.The following information was provided by the initial reporter translated from basque to english : "after the cannula does not advance, the due makes a small backward movement to recanalize and in the second advance there is resistance so decides to remove the cannula and finding at it's exit that the needle had perforated the catheter.".
Additional Manufacturer Narrative
H6: investigation summary one photo was received by our quality team for evaluation.From the photo, the needle is observed to be pierced through the catheter.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the verbatim, ¿after a correct puncture in the vein, the cannula is advanced to be cannulated in the vein.It does not advance, the due makes a small backward movement to recanalize¿¿, the needle piercing through the catheter was most likely caused by an incorrect insertion technique.Users are recommended to follow the instructions stated in the instructions for use: if the needle is partially or completely withdrawn from the catheter tubing during insertion, do not re-insert the needle into the catheter tubing as damage may occur.Therefore, this non-conformance most likely occurred out of the manufacturing facility.

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER WITH WINGS AND BD MULTIGUARD¿ TECHNOLOGY
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15160971
• Report Number: 8041187-2022-00421
• Device Sequence Number: 17566613
• Product Code: FOZ
• UDI-Device Identifier: 00382903868117
• UDI-Public: 00382903868117
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K201717
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2022

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: 08/31/2024
• Device Model Number: 386811
• Device Catalogue Number: 386811
• Device Lot Number: 1232895
• 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: 07/08/2022
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2021
• 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