MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA DIFFUSICS 22G X 1.00 IN; INTRAVASCULAR CATHETER

Catalog Number	383591
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd nexiva diffusics 22g x 1.00 in catheter was defective / damaged it was reported by customer that, while gauge iv inserted into vein.Unable to advance because catheter had a hole in it.++ bleeding at site, unable to advance, iv pulled.Verbatim: problem information complaint (b)(4) gauge iv inserted into vein.Unable to advance because catheter had a hole in it.++ bleeding at site, unable to advance, iv pulled.Occurrences: 1 ea.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 1 used sample and 1 photo submitted for evaluation.The reported issue of catheter defective / damaged was confirmed upon inspection of the samples.Analysis of the sample showed that a piercing was observed in the catheter.Bd was unable to determine the cause of the failure due to the unknown batch number, so the device history records could not be reviewed.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: BD NEXIVA DIFFUSICS 22G X 1.00 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
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21151954
• Report Number: 9610847-2024-00413
• Device Sequence Number: 9097633
• Product Code: FOZ
• UDI-Device Identifier: 00382903835911
• UDI-Public: (01)00382903835911
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2025

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: Health Professional
• Device Catalogue Number: 383591
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown