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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD¿ PRN ADAPTER; INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD¿ PRN ADAPTER; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 388638
Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/27/2022
Event Type  malfunction  
Event Description
It was reported that the bd¿ prn adapter experienced a loose prn connection, and leakage.The following information was provided by the initial reporter: the patient has had deep vein catheterization for nearly 1 month, and prn is used to seal the catheter every day.When it was used the latex stopper of the prn fell off, causing extravasation of blood, resulting in insufficient drug intake and the risk of infection.At that time, the nurse immediately replaced the prn.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
A device history review was conducted for lot number 1313600.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.H3 other text : see h10.
 
Event Description
It was reported that the bd¿ prn adapter experienced a loose prn connection, and leakage.The following information was provided by the initial reporter: the patient has had deep vein catheterization for nearly 1 month, and prn is used to seal the catheter every day.When it was used the latex stopper of the prn fell off, causing extravasation of blood, resulting in insufficient drug intake and the risk of infection.At that time, the nurse immediately replaced the prn.
 
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Brand Name
BD¿ PRN ADAPTER
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 Key16040043
MDR Text Key308243589
Report Number3014704491-2022-00701
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 01/06/2023
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 Number388638
Device Lot Number1313600
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/05/2022
Initial Date FDA Received12/22/2022
Supplement Dates Manufacturer Received01/06/2023
Supplement Dates FDA Received01/22/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/09/2021
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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