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

Model Number	383594
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd nexiva¿ diffusics¿ closed iv catheter system, the device experienced the needle perforating through the catheter.This event occurred four times.The following information was provided by the initial reporter.The customer stated: the catheter has is damage by the point of the needle where it is introduce to the body customer said it had happened 4 times and he has one of the product to return for investigation.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 when using the bd nexiva¿ diffusics¿ closed iv catheter system, the device experienced the needle perforating through the catheter.This event occurred four times.The following information was provided by the initial reporter.The customer stated: the catheter has is damage by the point of the needle where it is introduce to the body customer said it had happened 4 times and he has one of the product to return for investigation.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-10-18 investigation summary: bd received 1 sample submitted for evaluation.The reported issue was not confirmed upon inspection of the sample, since no defect was observed when the tip of the needle was observed with a microscope.Since the reported failure was not confirmed a root cause related to our manufacturing process cannot be established.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12755289
• Report Number: 9610847-2021-00534
• Device Sequence Number: 4614290
• Product Code: FOZ
• UDI-Device Identifier: 30382903835943
• UDI-Public: 30382903835943
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 11/08/2021

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: Other
• Device Expiration Date: 01/31/2024
• Device Model Number: 383594
• Device Catalogue Number: 383594
• Device Lot Number: 1015996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2021
• Supplement Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2021
• 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