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

Catalog Number	383592
Medical Device Problem Codes	Leak/Splash (1354); Defective Device (2588)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	11/15/2022
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 by the customer that the bd nexiva¿ diffusics¿ closed iv catheter system sprayed out.The following information was provided by the initial reporter: while placing the catheter, rn was pulling back the needle and while doing so blood came out and sprayed rn in the chest.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 15-dec-2022.H6: investigation summary: our quality engineer inspected the 1 sample and 1 photo submitted for evaluation.The reported issues of catheter damaged/defective (blood exposure) and blood excess / splash / spill / exposure were not confirmed upon inspection and testing of the sample.Analysis of the sample showed that there were no abnormalities or damages present on the returned sample.The sample underwent leakage testing and the sample passed with no signs of leakage.Bd cannot determine a manufacturing related root cause since the defect was not confirmed in testing.Dhr for this lot was reviewed and there are 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, and no issues were detected during manufacturing process.
Event or Problem Description
It was reported by the customer that the bd nexiva¿ diffusics¿ closed iv catheter system sprayed out.The following information was provided by the initial reporter: while placing the catheter, rn was pulling back the needle and while doing so blood came out and sprayed rn in the chest.

• Brand Name: BD NEXIVA¿ DIFFUSICS¿ 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 ; 8015296192
• MDR Report Key: 15936375
• Report Number: 9610847-2022-00460
• Device Sequence Number: 6200613
• Product Code: FOZ
• UDI-Device Identifier: 50382903835923
• UDI-Public: 00382903835928
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K123734
• 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): 01/20/2023

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: 07/31/2025
• Device Catalogue Number: 383592
• Device Lot Number: 2201690
• 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: 11/15/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2022
• 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