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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 ADMINISTRATION SET
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BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD¿ PRN ADAPTER; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 388638
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/14/2022
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone #: (b)(6).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 they found black spots in the bd¿ prn adapter before use and unused.The following information was provided by the initial reporter, translated from chinese to english: unopened heparin cap black spots found before use, unused.
 
Event Description
It was reported that they found black spots in the bd¿ prn adapter before use and unused.The following information was provided by the initial reporter, translated from chinese to english: unopened heparin cap black spots found before use, unused.
 
Manufacturer Narrative
H6: investigation summary: 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.Although photos were submitted for evaluation, the affected 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.
 
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Brand Name
BD¿ PRN ADAPTER
Type of Device
INTRAVASCULAR ADMINISTRATION SET
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 Key16148417
MDR Text Key308474342
Report Number3014704491-2022-00740
Device Sequence Number1
Product Code FPA
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 02/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number388638
Device Lot Number1313602
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/10/2023
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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