MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM 20 GA 1.00 IN; INTERVASCULAR CATHETER

Catalog Number 383693

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2021

Event Type  malfunction  

Event Description

It was reported that the bd nexiva¿ diffusics¿ closed iv catheter system 20 ga 1.00 in experienced leakage at the septum.The following information was provided by the initial reporter: when the mandrel was pulled out of the pivc, blood flowed out of the membrane where the mandrel was pulled out and which should be completely closed.New pivc had to be put on patient.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd nexiva¿ diffusics¿ closed iv catheter system 20 ga 1.00 in experienced leakage at the septum.The following information was provided by the initial reporter: when the mandrel was pulled out of the pivc, blood flowed out of the membrane where the mandrel was pulled out and which should be completely closed.New pivc had to be put on patient.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Manufacturer Narrative

H.6.Investigation: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.A dhr could not be performed due to unknown lot#.The complaint could not be confirmed and the root cause is undetermined.

Event Description

It was reported that the bd nexiva¿ diffusics¿ closed iv catheter system 20 ga 1.00 in experienced leakage at the septum.The following information was provided by the initial reporter: when the mandrel was pulled out of the pivc, blood flowed out of the membrane where the mandrel was pulled out and which should be completely closed.New pivc had to be put on patient.

• Brand Name: BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM 20 GA 1.00 IN
• Type of Device: INTERVASCULAR 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: 13048565
• MDR Text Key: 285762090
• Report Number: 9610847-2021-00606
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K173354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383693
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1