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U.S. Department of Health and Human Services

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

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BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA-II Y PRN/EC SLM INTRAVASCULAR CATHETER Back to Search Results
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
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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.
 
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Brand NameBD INTIMA-II Y PRN/EC SLM
Type of DeviceINTRAVASCULAR 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 Key14601682
MDR Text Key301241282
Report Number3014704491-2022-00208
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received06/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number383064
Device Lot Number1230660
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/18/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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