MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Model Number	383576
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd nexiva¿ closed iv catheter system the catheter kinked during infusion.There was no report of patient impact.The following information was provided by the initial reporter: rn started peripheral iv, flash noted, and catheter threaded without difficulty.Flash stopped at the end of the tubing, rn attempted to flush catheter and immediately encountered resistance.Patient reported no pain at side.Rn removed peripheral iv catheter; end of catheter tip bent significantly but intact.
Event or Problem Description
It was reported while using bd nexiva¿ closed iv catheter system the catheter kinked during infusion.There was no report of patient impact.The following information was provided by the initial reporter: rn started peripheral iv, flash noted, and catheter threaded without difficulty.Flash stopped at the end of the tubing, rn attempted to flush catheter and immediately encountered resistance.Patient reported no pain at side.Rn removed peripheral iv catheter; end of catheter tip bent significantly but intact.
Additional Manufacturer Narrative
H6: investigation summary it was reported the end of catheter tip was bent significantly post insertion.As no physical sample or picture sample was provided for evaluation by our quality engineer team, a complete investigation could not be performed.A device history record review was completed for provided material number 383576, lot 3026529.The review revealed there were no internal rejects related to the reported issue by the customer.According to the quality records all the inspections of the sampling plan met the acceptance criteria.An additional device history was reviewed for the subassembly unit used in the manufacturing of this batch and no related quality issues or deviations were found during the manufacture of the subassembly batch.Based on the investigation, bd was not able to confirm the defect or associate the incidence with the manufacturing process.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17240471
• Report Number: 9610847-2023-00167
• Device Sequence Number: 20507791
• Product Code: FOZ
• UDI-Device Identifier: 00382903835768
• UDI-Public: (01)00382903835768
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2023

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: Other
• Device Expiration Date: 01/31/2026
• Device Model Number: 383576
• Device Catalogue Number: 383576
• Device Lot Number: 3026529
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2023
• 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