MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA SINGLE PORT 24GA 0.75IN (0.7 MM X 19 MM); INTERVASCULAR CATHETER

Catalog Number 383511

Device Problem Leak/Splash (1354)

Patient Problems Extravasation (1842); Infiltration into Tissue (1931)

Event Date 05/13/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a bd nexiva single port 24ga 0.75in (0.7 mm x 19 mm) experienced catheter infiltration/extravasation, causing a serious injury in the form of infiltration.The following information was provided by the initial reporter: material no.: 383511 batch no.: 9053857.We use your 24 ga 0.75 in 0.7 x 19 mm catheter in our infusion room.Recently we have had several patients infiltrate and i¿m wondering if there possibly could be an issue with the catheter itself.We have used these for several years, and the same person is starting ivs with them.The catheter infiltrated intravascularly.There was no leakage of blood or body fluid outside of the body.

Manufacturer Narrative

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.A review of the device history record was performed and no quality issues were found during production.Conclusion(s): relationship of device to the reported incident: indeterminate.

Event Description

It was reported that a bd nexiva single port 24ga 0.75in (0.7 mm x 19 mm) experienced catheter infiltration/extravasation, causing a serious injury in the form of infiltration.The following information was provided by the initial reporter: material no.383511, batch no.9053857.We use your 24 ga 0.75 in 0.7 x 19 mm catheter in our infusion room.Recently we have had several patients infiltrate and i am wondering if there possibly could be an issue with the catheter itself.We have used these for several years and the same person is starting ivs with them.The catheter infiltrated intravascularly.There was no leakage of blood or body fluid outside of the body.

• Brand Name: BD NEXIVA SINGLE PORT 24GA 0.75IN (0.7 MM X 19 MM)
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8664737
• MDR Text Key: 146900392
• Report Number: 1710034-2019-00588
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835110
• UDI-Public: 30382903835110
• Combination Product (y/n): N
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 383511
• Device Lot Number: 9053857
• Date Manufacturer Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16 YR
• Patient Weight: 48