MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. NEXIVA 20 GA X 1-3/4 IN SINGLE PORT; INTRAVASCULAR CATHETER

Catalog Number	383518
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that nexiva 20 ga x 1-3/4 in single port tubing expanded.The following information was provided by the initial reporter: material no.: 383518 batch no.: 0063597.It was reported that nexiva tubing expanded significantly, but did not rupture.Per email: date of occurrence: (b)(6) 2021, reported to me on 3/1/21.Placement date: (b)(6) 2021.Explant date: (b)(6) 2021.Placement info: unknown.What type of catheter securement was utilized: tegaderm.A detailed description of the event: device placed using ultrasound for an outpatient ct.Excellent blood return on insertion.Ct ran at 325 psi 4ml/sec using omnipaque 350, cta of chest/abdomen/pelvis.Scan did not complete and tubing on nexiva expanded significantly right before the pink platform, but did not rupture.Ct has been notified that nexiva is rated at a max of 300 psi.Was there patient harm reported?:no.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-03-29 h6: investigation summary our quality engineer inspected the sample submitted for evaluation.Bd received one used nexiva catheter assembly with a needleless connector.Upon inspection of the received unit, it was observed that the extension tubing was ballooned near the connection to the winged adapter confirming the reported defect.The ifu states the maximum power injector pressure limit setting of 300 psi.The reported pressure used was 325 psi which was above specification.No other damage was noted to the unit indicating that exceeding specification likely resulted in the ballooning of the extension tubing.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.
Event or Problem Description
It was reported that nexiva 20 ga x 1-3/4 in single port tubing expanded.The following information was provided by the initial reporter: material no.: 383518 batch no.: 0063597 it was reported that nexiva tubing expanded significantly, but did not rupture.Per email: 1.Date of occurrence: 2/25/21, reported to me on 3/1/21 1.Placement date: (b)(6) 2021 2.Explant date: (b)(6) 2021 3.Placement info: unknown 4.What type of catheter securement was utilized: tegaderm 5.A detailed description of the event: device placed using ultrasound for an outpatient ct.Excellent blood return on insertion.Ct ran at 325 psi 4ml/sec using omnipaque 350, cta of chest/abdomen/pelvis.Scan did not complete and tubing on nexiva expanded significantly right before the pink platform, but did not rupture.Ct has been notified that nexiva is rated at a max of 300 psi.6.Was there patient harm reported?:no.

• Brand Name: NEXIVA 20 GA X 1-3/4 IN SINGLE PORT
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 11572696
• Report Number: 1710034-2021-00236
• Device Sequence Number: 17178444
• Product Code: FOZ
• UDI-Device Identifier: 00382903835188
• UDI-Public: 00382903835188
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• 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): 05/14/2021

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: 02/28/2023
• Device Catalogue Number: 383518
• Device Lot Number: 0063597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1