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

Model Number	386815
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
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 2 bd cathena¿ safety iv catheters with wings bd multiguard¿ technology had issues with the needle piercing through the catheter, resulting in blood leakage through the hole.The following information was provided by the initial reporter: "2 separate rns experienced same incident in same day and neither had experienced it prior despite using product for some time- during iv start, needle went through plastic cathelon resulting in blood flow through hole in cathelon and failed iv start.".
Additional Manufacturer Narrative
The following fields were updated due to corrected information: d.10.Device available for eval?: no.D.10.Returned to manufacturer on: na.H.6.Investigation: one photo was received by our quality team for evaluation.From the photo, a portion of the catheter was observed to be flattened.A device history record review found no non-conformances associated with this issue during production of this batch.The flattened catheter could have occurred after application, however, as no sample was received, the root cause could not be established.
Event or Problem Description
It was reported that 2 bd cathena¿ safety iv catheters with wings bd multiguard¿ technology had issues with the needle piercing through the catheter, resulting in blood leakage through the hole.The following information was provided by the initial reporter: "2 separate rns experienced same incident in same day and neither had experienced it prior despite using product for some time- during iv start, needle went through plastic cathelon resulting in blood flow through hole in cathelon and failed iv start.".

• Brand Name: BD CATHENA SAFETY IV CATHETER WITH WINGS BD MULTIGUARD TECHNOLOGY
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11638796
• Report Number: 8041187-2021-00259
• Device Sequence Number: 3496735
• Product Code: FOZ
• UDI-Device Identifier: 00382903868155
• UDI-Public: 00382903868155
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021

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: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 386815
• Device Catalogue Number: 386815
• Device Lot Number: 8183073
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/06/2021
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1