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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE-W WINGED; PERIPHERAL IV CATHETERS

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BECTON DICKINSON BD INSYTE-W WINGED; PERIPHERAL IV CATHETERS Back to Search Results
Catalog Number 381312
Device Problem Material Fragmentation (1261)
Patient Problem Foreign Body Embolism (4439)
Event Date 02/21/2024
Event Type  Injury  
Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.E1.Address information was not provided, therefore, xx was used as a place holder.In this mdr, (b)(6) has been listed in sections d.3.And g.1.
 
Event Description
It was reported that bd insyte-w winged catheter broke.The following information was provided by the initial reporter, translated from chinese to english: at around 10:00 on (b)(6) 2024, the indwelling needle was punctured successfully, ordinary drugs were injected, the fluid was unobstructed, and the indwelling needle hose was found to be broken at 08:26 on (b)(6) 2024.The tube of the child's indwelling needle- was broken and the tip was incomplete.At 08:26 on (b)(6) 2024, the patient's family rang the bedside call bell and complained that the patient's indwelling needle hose was broken.They immediately checked the child and found that the tape at the child's indwelling needle was loose and there was blood scab at the application site.The stump of the needle hose was exposed about 0.7cm, and 1.2cm was missing.An urgent color ultrasound of the veins of the left upper limb and a color ultrasound of the body surface soft tissue were performed.The color ultrasound results showed that a 15mm long linear strong echo was seen in the subcutaneous superficial vein.Report to the hospital, notify the company, and transfer to a (b)(6) hospital for further treatment.
 
Manufacturer Narrative
Cancel mdr complaint is a duplicate.Information captured in mdr 9870050 mfr.Report # 2243072-2024-00285.
 
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Brand Name
BD INSYTE-W WINGED
Type of Device
PERIPHERAL IV CATHETERS
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
helen cox (mdr)
75 north fairway drive
vernon hills, IL 60061
8473935694
MDR Report Key18921609
MDR Text Key337871754
Report Number2243072-2024-00291
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903813124
UDI-Public(01)00382903813124
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K151698
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number381312
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/26/2024
Initial Date FDA Received03/18/2024
Supplement Dates Manufacturer Received02/26/2024
Supplement Dates FDA Received03/18/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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