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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¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383078
Device Problems Break (1069); Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/29/2021
Event Type  malfunction  
Event Description
It was reported that the bd intima-ii¿ closed iv catheter system split and broke from the hub during use. The following information was provided by the initial reporter, translated from (b)(6) to english: " the catheter tube was fractured, but it was not found in the body of the film. It was preliminary determined that the child had bitten off and swallowed. The substance similar to catheter was found later, and it was sent back to the factory to determine whether it was a catheter. ".
 
Manufacturer Narrative
Investigation summary: in response to the event reported, a device history review was conducted for lot number 9050858. 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. According to feedback, the broken catheter is most likely related to the behavior of the patient and unrelated to the manufacturing process. To rule out the possibility of a systemic issue in the reported lot, the retention samples have been tested for tensile resistance and were found to conform to product specifications. Unfortunately without the ability to inspect the affected device, the root cause cannot be confirmed at this time. Bd will continue to track and trend for this issue.
 
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Brand NameBD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12523336
MDR Text Key280834245
Report Number3014704491-2021-00159
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,Followup
Report Date 11/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number383078
Device Lot Number1050044
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/19/2021
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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