MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II 24GAX0.75IN PRN; INTRAVASCULAR CATHETER

Catalog Number 383083

Device Problem Complete Blockage (1094)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that the bd intima-ii 24gax0.75in prn catheter was kinked/bent.The following information was provided by the initial reporter translated from chinese to english: "the patient was hospitalized in our hospital on (b)(6) 2024 for treatment of bronchitis, and when he was given intravenous fluids, he was found to have an abnormal bending of the indwelling needle, which was immediately replaced with a new and normal indwelling needle to continue to complete the treatment, which had no effect on the patient.".

Manufacturer Narrative

Pr# (b)(4).Follow up report for additional information/correction and device evaluation.Additional information/correction: event details were provided after the initial mdr was submitted; discovered before infusion/needle was bent before infusion.The event/product problem was incorrect in the initial mdr.Correct event/product problem is needle bent.Device evaluation: in response to the event reported by the facility, a device history review was conducted for lot number 3290312.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 and/or photo, was not received for evaluation and testing; the bending site, bending angle, and bending direction of the needle cannot be identified.In lieu of the affected device, visual analysis was performed on retention samples for this lot, the retained devices were found to be free of any damage or other abnormalities.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.

Event Description

Additional information provided by customer: please follow up with the customer if they meant the catheter was bent during infusion or if the needle was bent before infusion? discovered before infusion.

• Brand Name: BD INTIMA-II 24GAX0.75IN PRN
• Type of Device: INTRAVASCULAR CATHETER
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19112203
• MDR Text Key: 340909194
• Report Number: 3002601200-2024-00133
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830831
• UDI-Public: (01)00382903830831
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K200891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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: Health Professional
• Device Catalogue Number: 383083
• Device Lot Number: 3290312
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1