MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number	383518
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Overdose (1988)
Date of Event	10/11/2019
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 that the bd nexiva¿ closed iv catheter system tubing "blew" during use and contrast leaked from it.As a result, the ct scan was not completed and the patient did not receive the full ct contrast dose.A new iv was placed, but a repeat ct scan was "not needed".The following information was provided by the initial reporter: "iv tubing blew and contrast leaked.The rate and contrast used were within the manufacturer's guideline.(isovue 300; 5.5 ml/sec)" "ct scan was incomplete due to the contrast leak.Pt.Did not receive full ct contrast dose.New iv placed.A repeat ct scan was not needed.".
Additional Manufacturer Narrative
H.6.Investigation summary: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this event but without a sample no corrective actions could be identified.A review of the device history record was performed and no quality issues were found during production.H3 other text : see section h.10.
Event or Problem Description
It was reported that the bd nexiva¿ closed iv catheter system tubing "blew" during use and contrast leaked from it.As a result, the ct scan was not completed and the patient did not receive the full ct contrast dose.A new iv was placed, but a repeat ct scan was "not needed".The following information was provided by the initial reporter: "iv tubing blew and contrast leaked.The rate and contrast used were within the manufacturer's guideline.(isovue 300; 5.5 ml/sec)".

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 9244881
• Report Number: 1710034-2019-01147
• Device Sequence Number: 13805426
• Product Code: FOZ
• UDI-Device Identifier: 30382903835189
• UDI-Public: 30382903835189
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 383518
• Device Lot Number: 9150812
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Weight: 84