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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 22GAX1.00IN PRN SLM NPVC INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA-II 22GAX1.00IN PRN SLM NPVC INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383064
Device Problems Delivered as Unsterile Product (1421); Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/07/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: in response to the event a device history review was conducted for lot number 1076043. 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, visual analysis was performed on retention samples for this lot, the retained devices were found to be free of any damage or other abnormalities. Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint. Bd will continue to monitor this issue.
 
Event Description
It was reported that bd intima-ii 22gax1. 00in prn slm npvc had a needle through the cover and had damaged unit package that compromised sterility. The following information was provided by the initial reporter: "the nurse found that the protective sleeve of the indignant needle was damaged and the needle punctured the aseptic bag, which made it unusable. ".
 
Manufacturer Narrative
Investigation summary: in response to the event a device history review was conducted for lot number 1076043. 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, visual analysis was performed on retention samples for this lot, the retained devices were found to be free of any damage or other abnormalities. Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint. Bd will continue to monitor this issue.
 
Event Description
It was reported that bd intima-ii 22gax1. 00in prn slm npvc had a needle through the cover and had damaged unit package that compromised sterility. The following information was provided by the initial reporter: "the nurse found that the protective sleeve of the indignant needle was damaged and the needle punctured the aseptic bag, which made it unusable. ".
 
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Brand NameBD INTIMA-II 22GAX1.00IN PRN SLM NPVC
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 Key12962393
MDR Text Key285939239
Report Number3014704491-2021-00333
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 11/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number383064
Device Lot Number1076043
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/17/2021
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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