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

Catalog Number 383028

Device Problem Break (1069)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 05/16/2023

Event Type  malfunction  

Manufacturer Narrative

H3.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 iv catheter was broken.The following information was provided by the initial reporter: "in the department of cardiology, the extension tube was found to be broken during the use of the product.The breakage of the extension tube of the indwelling needle was discovered by the nurse during the ward round the next morning.On (b)(6) 2023, when the nurse was on shift, it was found that the patient's indwelling needle was broken and the blood had coagulated, so there was no major bleeding, but the vasopressor was not given continuously, resulting in low blood pressure of the patient.After the discovery, a new indwelling needle was replaced, and the drug was continued, and the patient's blood pressure improved.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 18-may-2023 investigation summary a device history review was conducted for lot number 2290452.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.Additionally a sample was returned to aid in our investigation.Our engineers noted that the returned unit displayed a bifurcated extension tube, which separated approximately 3mm away from the adapter junction.This nonconformance has been confirmed.Closer inspection of the broken edge of the device was able to identify a smooth edge to the damaged tubing, which is inconsistent with damage from clamping.Clamping damage displays tell-tale whitening of the tubing at the cleavage site, m and a aged torn edge.The observed damage is more reminiscent of characteristics consistent with contact of a sharped edge or implement, however this cannot be confirmed by observation of the device alone.Unfortunately our quality engineers were unable to confirm the root cause for this complaint.

Event Description

It was reported that the bd intima-ii iv catheter was broken.The following information was provided by the initial reporter: "in the department of cardiology, the extension tube was found to be broken during the use of the product.The breakage of the extension tube of the indwelling needle was discovered by the nurse during the ward round the next morning.On (b)(6) 2023, when the nurse was on shift, it was found that the patient's indwelling needle was broken and the blood had coagulated, so there was no major bleeding, but the vasopressor was not given continuously, resulting in low blood pressure of the patient.After the discovery, a new indwelling needle was replaced, and the drug was continued, and the patient's blood pressure improved.".

• Brand Name: BD INTIMA-II IV CATHETER
• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17101466
• MDR Text Key: 317027018
• Report Number: 3014704491-2023-00249
• 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: 06/16/2023

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: 383028
• Device Lot Number: 2290452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 06/09/2023
• Supplement Dates Manufacturer Received: 06/16/2023
• Supplement Dates FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2022
• 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