MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA-II Y PRN/EC SLM; INTRAVASCULAR CATHETER

Catalog Number 383064

Device Problem Defective Device (2588)

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

Event Date 05/10/2022

Event Type  malfunction  

Manufacturer Narrative

In response to the event reported a device history review was conducted for lot number 1230660.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.The provided photograph clearly displays that the catheter tubing has suffered damage in the center of the tubing.Unfortunately, our engineers were unable to locate the damage in the returned device through enhanced visual analysis or functional testing.Our engineers were b=unable to determine a root cause without the ability evaluate the non-conformance in the lab.Bd will continue to track and trend for this issue.

Event Description

It was reported while using bd intima-ii y prn/ec slm the catheter tube broke.There was no report of patient impact.The following information was provided by the initial reporter: on (b)(6) 2022, when the nurse of the emergency department performed the indwelling needle puncture for the patient, the blood leakage at the catheter tube was found after the successful puncture and withdrawal of the steel needle, which was caused by breakage in the middle of the catheter tube.

• Brand Name: BD INTIMA-II Y PRN/EC SLM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer (Section G): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14601682
• MDR Text Key: 301241282
• Report Number: 3014704491-2022-00208
• 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
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383064
• Device Lot Number: 1230660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• 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