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 Puncture/Hole (1504)
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 that bd nexiva¿ diffusics¿ closed iv catheter system had a hole in the catheter.The following information was provided by the initial reporter: "it was reported holes on the catheter".
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation: unfortunately, the sample was lost either in-transit to the testing facility or upon receipt at the testing facility.No further investigation can be performed at this time.A device history record review showed no non-conformances associated with this issue during the production of this batch.The complaint could not be confirmed and the root cause is undetermined.
Event or Problem Description
It was reported that bd nexiva¿ diffusics¿ closed iv catheter system had a hole in the catheter.The following information was provided by the initial reporter: "it was reported holes on the catheter".
Event or Problem Description
It was reported that bd nexiva¿ diffusics¿ closed iv catheter system had a hole in the catheter.The following information was provided by the initial reporter: "it was reported holes on the catheter.".
Additional Manufacturer Narrative
The investigation has been updated: h.3.Device eval by manufacturer? yes.H.6.Investigation summary: the samples returned for the investigation were found at our bd manufacturing facility.Our quality engineer inspected the 4 opened and 15 unopened samples submitted for evaluation.The reported issue was confirmed upon inspection of the samples.The damage observed on the samples is referred to as back wall damage.Bd determined that the cause of the failure was associated to the laser drilling process during manufacturing.A laser is used to mark the diffusics holes and some burning of the catheter material tends to occur.In this instance the laser burned through the catheter causing damages outside of the manufacturing parameters.A quality alert was generated and issued out to all manufacturing personnel involved with this product to increase awareness and prevent further reoccurrence.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

• 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: 12964812
• Report Number: 9610847-2021-00589
• Device Sequence Number: 4416383
• 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: K173354
• 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,Followup
• Report Date (Section B): 03/14/2022

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 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: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 01/31/2022; 03/14/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 02/09/2022; 03/20/2022
• 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