MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number 383033

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2022

Event Type  malfunction  

Event Description

It was reported that leakage occurred at adapter and tubing of bd intima-ii¿ closed iv catheter system.No patient impact reported.The following information was provided by the initial reporter, translated from chinese to english: the head nurse of the department of cardiology reported that fluid leakage was found at the junction between the extension tube and the needle hub during use of the product.

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: dhr is not performed as the lot number is "unknown" for this complaint.1 photo was returned from the customer.The photo shows that the sample gauge is 24g, and the leakage is marked in red as the connection between the extension tubing and the connection site.As the defective sample was not returned, the specific damage status of this area cannot be determined.Conclusion(s): the returned photo shows that the connection between the extension tubing and the connection site is leakage.As no defective sample returned, the specific damage state cannot be determined, so the root cause cannot be determined.The plant will continue to track and pay attention to this area of damage.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15033514
• MDR Text Key: 303925336
• Report Number: 3014704491-2022-00279
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K200891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 383033
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2022
• 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