MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II; INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problems Fluid/Blood Leak (1250); Defective Component (2292)

Patient Problem Discomfort (2330)

Event Date 11/01/2023

Event Type  malfunction  

Event Description

It was reported that bd unknown intima ii leaked.The following information was provided by the initial reporter; (b)(6), 2023 icu patient li zeming due to the diagnosis of chronic obstructive pulmonary disease transferred to the department of radiology at 9:30 to the ct room to do coronary ct examination, in accordance with medical advice to give the indwelling needle for intravenous injection of iodine contrast agent left at the connector of the tube suddenly burst, resulting in the patient's iodine contrast agent can not enter the vein, and immediately re-replaced the intravenous indwelling needle with the patient with a high-pressure syringe injection of contrast medium, at 09:40 to complete the injection of contrast medium the injection of contrast agent was completed at 09:40, which was normal, causing an adverse event of delayed examination and repeated injections to the patient.

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Manufacturer Narrative

A complaint history check was unable to be performed since no material, lot/batch number was provided.A device history review was unable to be performed since no material, lot/batch number was provided.A retain sample analysis could not be performed as no batch/lot number was made available for this reported event.A review of the applicable risk documentation indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.The reported defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.

Event Description

No additional information available.

• Brand Name: BD INTIMA-II
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18276130
• MDR Text Key: 330818581
• Report Number: 3014704491-2023-00800
• Device Sequence Number: 1
• Product Code: FOZ
• 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,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 03/05/2024
• Supplement Dates FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2023
• 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