MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA CLOSED IV CATHETER SYSTEM - DUAL PORT 24 GA 0.75 IN; INTRAVASCULAR CATHETER

Catalog Number	383541
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.(b)(4).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 the bd nexiva¿ closed iv catheter system - dual port 24 ga 0.75 in experienced needle through catheter during introduction.The following information was provided by the initial reporter: material no.383541 batch no.Unknown.It was reported that there was a material puncture.No health consequences or impacte2401 - insufficient informationa041001 - material puncture / holeb01 - testing of actual/suspected devicec21 - results pending completion of investigationd14 - no problem detected.Event details was pulled from ¿health canada¿s medical devices online databases".

• Brand Name: BD NEXIVA CLOSED IV CATHETER SYSTEM - DUAL PORT 24 GA 0.75 IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 10653980
• Report Number: 9610847-2020-00317
• Device Sequence Number: 18908079
• Product Code: FOZ
• UDI-Device Identifier: 00382903835416
• UDI-Public: 00382903835416
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2020

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 Catalogue Number: 383541
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/09/2020
• 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