MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA SINGLE PORT 24GA 0.56IN (0.7 MM X 14 MM); INTERVASCULAR CATHETER

Catalog Number	383510
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.Device manufacture date: unknown.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 a bd nexiva single port 24ga 0.56in (0.7 mm x 14 mm) had leakage.The following was reported, "material no: 383510 batch no: unknown.It was reported that catheter appeared to have partially broke and the site started bleeding.Per customer email: we did have another issue yesterday ((b)(6) 2018).We were trying to start an iv on a 15mon pt admitted with resp distress, dehydration, and fever (room 470).On the first stick, i stuck her left hand.I got immediate flash and bleed back and as i went to advance the catheter, the catheter appeared to have partially broke as i was withdrawing the needle as the site started bleeding between the yellow wings and the actual insertion site.We immediately removed the catheter and ensured the tip was intact.The catheter we saved and is in a biohazard bag labeled with the patients sticker and we gave it to day shift to give you.".
Additional Manufacturer Narrative
Investigation summary: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.The complaint was deemed as mdr reportable therefore a submission will be performed.Shall a sample or lot number become available, the complaint will be re-opened and an investigation will take place.This complaint will be closed at this time.
Event or Problem Description
It was reported that a bd nexiva single port 24ga 0.56in (0.7 mm x 14 mm) had leakage.The following was reported, "material no: 383510.Batch no: unknown.It was reported that catheter appeared to have partially broke and the site started bleeding.Per customer email: we did have another issue yesterday (b)(6)18).We were trying to start an iv on a 15mon pt admitted with resp distress, dehydration, and fever (room 470).On the first stick, i stuck her left hand.I got immediate flash and bleed back and as i went to advance the catheter, the catheter appeared to have partially broke as i was withdrawing the needle as the site started bleeding between the yellow wings and the actual insertion site.We immediately removed the catheter and ensured the tip was intact.The catheter we saved and is in a biohazard bag labeled with the patients sticker and we gave it to day shift to give you.".

• Brand Name: BD NEXIVA SINGLE PORT 24GA 0.56IN (0.7 MM X 14 MM)
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8444710
• Report Number: 1710034-2019-00326
• Device Sequence Number: 16888458
• Product Code: FOZ
• UDI-Device Identifier: 00382903835102
• UDI-Public: 00382903835102
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K161777
• Number of Events Summarized: 1
• Summary Report (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): 04/08/2019

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 Catalogue Number: 383510
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 04/08/2019
• 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