MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETE

Catalog Number 383083

Device Problem Material Perforation (2205)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/31/2022

Event Type  malfunction  

Event Description

It was reported that the bd intima-ii¿ closed iv catheter system experienced the following information was provided by the initial reporter: the patient was given intravenous indwelling needle puncture for infusion therapy.The core of the indwelling needle did not match the hose (the core of the steel needle broke through the hose and the hose was not fed smoothly), resulting in children with ruptured blood vessels, the puncture was unsuccessful, to be re-punctured, and explain the communication work to the parents.

Manufacturer Narrative

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 the bd intima-ii¿ closed iv catheter system needle broke through the hose during use.The following information was provided by the initial reporter: the patient was given intravenous indwelling needle puncture for infusion therapy.The core of the indwelling needle did not match the hose (the core of the steel needle broke through the hose and the hose was not fed smoothly), resulting in children with ruptured blood vessels, the puncture was unsuccessful, to be re-punctured, and explain the communication work to the parents.

Manufacturer Narrative

The following field was updated due to corrections: b.5.Describe event or problem: it was reported that the bd intima-ii¿ closed iv catheter system needle broke through the hose during use.H.6.Investigation summary: in response to the event reported, a device history review was conducted for lot number 2110919.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Bd will continue to monitor this issue.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETE
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15921582
• MDR Text Key: 305820650
• Report Number: 3014704491-2022-00635
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/11/2022

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
• Device Operator: Other
• Device Catalogue Number: 383083
• Device Lot Number: 2110919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 12/11/2022
• Supplement Dates FDA Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1