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

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.

• 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 Key: 18921609
• MDR Text Key: 337871754
• Report Number: 2243072-2024-00291
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903813124
• UDI-Public: (01)00382903813124
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151698
• Number of Events Reported: 1
• 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 Number: 381312
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other