MAUDE Adverse Event Report: BECTON DICKINSON BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number	383576
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H3.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 the bd nexiva¿ closed iv catheter system had a bulge near the extension wings.The following was received by the initial reporter: problem information cite customer ref (b)(4) 20g cathalon initiated to l acf.When returned from ct the nexiva 20g had a bulge in the extension by the wings.The bulge was right beside the wing as it comes out to the extension.
Event or Problem Description
It was reported the bd nexiva¿ closed iv catheter system had a bulge near the extension wings.The following was received by the initial reporter: problem information.Cite customer ref#(b)(4) 20g cathalon initiated to l acf.When returned from ct the nexiva 20g had a bulge in the extension by the wings.The bulge was right beside the wing as it comes out to the extension.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 22-aug-2023.H6: investigation summary: bd received an unsealed 20 gauge nexiva dual port unit from an unknown lot for evaluation.A review of the device history record could not be performed as the reported lot was unknown and could not be determined the returned unit.Our quality engineer visually inspected the returned unit and observed ballooning in the extension tubing near the end where it connects to the needle adapter.Next, the engineer flushed the device to identify if there was any occlusions or leakage.No leakage was found and the device flushed completely with no occlusions present.Upon further inspection the engineer was able to identify a kink in the tubing near where the ballooning was occurring.The kink resembled a clamp activation.Therefore, based off the visual inspection and testing the engineer was able to verify the reported defect.The engineer determined that the ballooned tubing was likely caused by this kink in the extension tubing.Unfortunately, the engineer was unable to determine a definitive root cause for the observed kink.The manufacturing facility has been notified of this incident and the findings.H3 other text : see h10.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17546995
• Report Number: 2243072-2023-01447
• Device Sequence Number: 15188320
• Product Code: FOZ
• UDI-Device Identifier: 00382903835768
• UDI-Public: (01)00382903835768
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2023

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 Catalogue Number: 383576
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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