MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA-II 18GAX1.16IN PRN SLM NPVC; CLOSED IV CATHETER SYSTEM

Catalog Number 383050

Device Problem Break (1069)

Patient Problem Foreign Body Embolism (4439)

Event Date 09/20/2023

Event Type  Injury  

Event Description

It was reported that bd intima-ii 18gax1.16in prn slm npvc broke during use.The following information was provided by the initial reporter translated from chinese to english: "due to vomiting and chills, he was sent to the emergency department by 120 ambulance.At about 9:15 on (b)(6) 2023, after blood was drawn through a closed intravenous indwelling needle, 500ml of compound sodium chloride injection was given intravenously.Due to the discovery of exudation, the indwelling needle needed to be removed.During the removal, it was found that the indwelling needle tube had broken off and remained in the patient's middle cubital vein.A tourniquet was immediately placed on the proximal end of the puncture port.After color ultrasound positioning, the patient was sent to the operating room for incision and removal.After taking it out, it was found that the stump of the needle tube was flat.After the operation, he was sent to the second department of orthopedics for hospitalization for observation.".

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.

• Brand Name: BD INTIMA-II 18GAX1.16IN PRN SLM NPVC
• Type of Device: CLOSED IV CATHETER SYSTEM
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17850938
• MDR Text Key: 324680379
• Report Number: 3014704491-2023-00612
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830503
• UDI-Public: (01)00382903830503
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• 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
• Report Date: 09/27/2023

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: Other
• Device Catalogue Number: 383050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention