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Catalog Number 383033
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/20/2020
Event Type  Injury  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4).
Event Description
It was reported that a intima-ii y 24gax0. 75in prn/ec slm broke at the catheter tube during use. The following was reported by the initial reporter: the catheter tube ruptured and the broken part was not found in the patient¿s body. On 2020-11-23, received an update from the sales representative. The event description is as follows: at around 16:00 on november 20, gao haidan (supervisor nurse), a geriatric nurse in taizhou municipal hospital, found that there was exudation and swelling at the puncture site of the indwelling needle in the patient's right hand. He removed the indwelling needle and planned to re-puncture the indwelling needle in the patient's left hand. On 16:18, dan with high sea (race 24 g batch number: 0168683 expiry time: 2023. 07. 15) indwelling needle puncture, embossed on the first arm vein indwelling needle with choice, pulls open the needle packaging after disinfection protection needle cap loose core, tip angle of up to 25 degrees or so (full) normal catheter indwelling needle check the needles are inserted into the needle to 6 mm or so did not see h. , feeling slightly bigger resistance, pull out the needle found missing hose around 5 mm, high sea dan let family pressure above the vessel in the indwelling needle puncture. On 16:21, gao haidan reported the incident to head nurse yuan, giving a venous tourniquet tied above the puncture point. On 16:22, the head nurse reported to director chen huabin of the department on 16:31, zhou yanxin, an employee of bd, talked to the head nurse and asked him to block the blood vessel to check whether there was a broken pipe near the puncture operation. Do an imaging study immediately to determine the location of the broken tube. On 17:35, imaging examination showed a 3mm long strip of strong echo in the left dorsal superficial vein, suggesting that the head nurse remove the catheter immediately he did not enter the operating room during 17:35-22:33 on 22:33, enter the operating room on 00:30, the head nurse told the rep that the operation failed to find a broken tube. On (b)(6) 2020, at 00:30, the head nurse told me that the operation failed to find a broken tube. On (b)(6) 2020, at 11:04, talked to he caidi, the nursing director of the hospital. Because the surgical catheter could not be found, it was suspected whether the suspected object was drifting along the vein during 17:35-22:33 on 20th. It is recommended to continue imaging to determine the location of the catheter. On (b)(6) 2020, b ultrasonic examination around 11:20 found no broken pipe. The clinical nurse indwelling the patient's vein, found resistance during the process of removing the needle, the anterior segment of the catheter was broken, and the residual body was found. Immediately, b-ultrasonography was given to diagnose, showing strong echo of the left dorsal superficial vein at the catheter fracture. The catheter was removed after surgery, but the operation was unsuccessful, and close observation was continued.
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Manufacturer (Section D)
no. 5 baiyu road
suzhou industrial park
Manufacturer (Section G)
no. 5 baiyu road
suzhou industrial park
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
MDR Report Key11032853
MDR Text Key223064760
Report Number3006948883-2020-01002
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number383033
Device Lot Number0168683
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/16/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/17/2020 Patient Sequence Number: 1