MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM 18 GA 1.25 IN; INTRAVASCULAR CATHETER

Model Number	383594
Medical Device Problem Codes	Defective Component (2292); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd nexiva¿ diffusics¿ closed iv catheter system 18 ga 1.25 in catheter was found to be deformed and bulging.The following information was provided by the initial reporter: material no: batch no: 1082458   it was reported by the consumer the ivs are bilging at the tip of the catheter, yellow and malformed.  verbatim: lot 1082458 of 18 gauge diffusics ivs are bulged out where the side ports are located at the tip of the catheter.This area is also yellow and malformed.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6.Investigation: our quality engineer inspected the 339 representative samples and 4 opened samples submitted for evaluation.The reported issue of catheter damage was not confirmed upon inspection and testing of the samples.A random sampling of the returned samples were tested for catheter penetration force to see if there was any catheter damage.During testing all samples were found to be within specification and had no defects.Bd cannot determine a manufacturing root cause since the defect was not confirmed.The reported issue of yellowing was confirmed upon inspection of the samples.The inspection of the samples found acceptable amounts of catheter yellowing on some of the samples.A laser is used during the production of these products and minor amounts of yellowing can occur due to the heat emitted from the laser.All samples examined were found to be within manufacturing specifications for the yellow discoloration.
Event or Problem Description
It was reported while using bd nexiva¿ diffusics¿ closed iv catheter system 18 ga 1.25 in catheter was found to be deformed and bulging.The following information was provided by the initial reporter: batch no: 1082458.It was reported by the consumer the ivs are bilging at the tip of the catheter, yellow and malformed.  verbatim: lot 1082458 of 18 gauge diffusics ivs are bulged out where the side ports are located at the tip of the catheter.This area is also yellow and malformed.

• Brand Name: BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM 18 GA 1.25 IN
• 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: 13441907
• Report Number: 9610847-2022-00041
• Device Sequence Number: 4327432
• Product Code: FOZ
• UDI-Device Identifier: 30382903835943
• UDI-Public: 30382903835943
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 02/23/2022

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: 03/31/2024
• Device Model Number: 383594
• Device Catalogue Number: 383594
• Device Lot Number: 1082458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 03/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• 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