MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD PRECISIONGLIDE NEEDLE; INTRAVASCULAR CATHETER

Catalog Number	383530
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2020
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.(b)(4).
Event or Problem Description
It was reported that the bd nexiva¿ closed iv catheter system - dual port 24 ga 0.56 in experienced defective/damaged tubing and leakage from tubing.The following information was provided by the initial reporter: a pharmacy manager informed bd of an issue that happened with a product.383530 lot 9144509 was inserted into the patient.The tubing had a pin hole in it and blood leaked thru it.
Event or Problem Description
It was reported that the bd nexiva¿ closed iv catheter system - dual port 24 ga 0.56 in experienced defective/damaged tubing and leakage from tubing.The following information was provided by the initial reporter: a pharmacy manager informed bd of an issue that happened with a product.383530 lot 9144509 was inserted into the patient.The tubing had a pin hole in it and blood leaked thru it.
Additional Manufacturer Narrative
Investigation: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.

• Brand Name: BD PRECISIONGLIDE NEEDLE
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 10991556
• Report Number: 1710034-2020-00792
• Device Sequence Number: 10950751
• Product Code: FOZ
• UDI-Device Identifier: 00382903835300
• UDI-Public: 00382903835300
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2020

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: 04/30/2022
• Device Catalogue Number: 383530
• Device Lot Number: 9144509
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1