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U.S. Department of Health and Human Services

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

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BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383033
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/08/2022
Event Type  malfunction  
Manufacturer Narrative
Initial reporter e-mail: unknown.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 prn on the bd intima-ii¿ closed iv catheter system was loose and fell off during use.The following information was provided by the initial reporter, translated from chinese: "at 10:10 on (b)(6) 2022, the indwelling needle on the back of the right hand was used for infusion.After the infusion was completed, the tube was sealed, and the patient rested in bed at night.The next day, the responsible nurse found that the prn of the indwelling needle had fell off, and the rest was intact.".
 
Manufacturer Narrative
Investigation summary: a device history review was conducted for lot number 2053259.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.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.
 
Event Description
It was reported that the prn on the bd intima-ii¿ closed iv catheter system was loose and fell off during use.The following information was provided by the initial reporter, translated from chinese: "at 10:10 on (b)(6) 2022.8, the indwelling needle on the back of the right hand was used for infusion.After the infusion was completed, the tube was sealed, and the patient rested in bed at night.The next day, the responsible nurse found that the prn of the indwelling needle had fell off, and the rest was intact.".
 
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Brand Name
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
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
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15676905
MDR Text Key306286869
Report Number3014704491-2022-00522
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903830336
UDI-Public(01)00382903830336
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 10/28/2022
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 Number383033
Device Lot Number2053259
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/02/2022
Initial Date FDA Received10/26/2022
Supplement Dates Manufacturer Received10/28/2022
Supplement Dates FDA Received11/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/22/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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