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

Model Number	386807
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd cathena¿ safety iv catheter with bd multiguard¿ technology there was leakage at the catheter and hub junction.The following information was provided by the initial reporter.The customer stated: "after catheter placement, the infusion was started and leakage was then observed.When the hcp checked the product, the leakage was occurring around the area between the catheter and the catheter hub.".
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Additional Manufacturer Narrative
H6: investigation summary three photos and two samples, one actual and one representative without packaging, were received by our quality team for evaluation.From the photos, leakage was observed at the end of the catheter tubing near the nose of the adapter.Both samples were subjected to the catheter leak test.The actual sample failed the leak test by leaking at the end of the catheter tubing near the nose of the adapter, while the representative sample passed.The actual sample was subjected to visual inspection for tubing damage.Two cuts were observed near the nose of the adapter.A device history record could not be evaluated as the lot number is unknown.The assembly process was reviewed, there is no station that has contact with the catheter tubing at this location which will cause the observed cuts on the catheter tubing.The cuts could be caused when the product was manipulated during product application.As the sample has been used, the actual root cause could not be established.H3 other text : see h10.
Event or Problem Description
It was reported when using the bd cathena¿ safety iv catheter with bd multiguard¿ technology there was leakage at the catheter and hub junction.The following information was provided by the initial reporter.The customer stated: "after catheter placement, the infusion was started and leakage was then observed.When the hcp checked the product, the leakage was occurring around the area between the catheter and the catheter hub.".

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER WITH 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: 12976874
• Report Number: 8041187-2021-01039
• Device Sequence Number: 20031114
• Product Code: FOZ
• UDI-Device Identifier: 00382903868070
• UDI-Public: 00382903868070
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172506
• 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): 01/10/2022

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: 386807
• Device Catalogue Number: 386807
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 01/20/2022
• 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