MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA II¿ IV CATHETER PRN ADAPTER; INTRAVASCULAR CATHETER

Catalog Number 383012

Device Problems Leak/Splash (1354); Structural Problem (2506)

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

Event Date 05/22/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date : unknown.Medical device manufacture date: unknown.Investigation summary: exec summary: no physical device samples were returned.Since no samples (including photos) displaying the condition reported are available for examination, bd were unable to fully investigate this incident to duplicate or confirm the customer¿s indicated failure and the root cause is therefor undetermined.No review of the complaint lot history check for ( catheter defective or damaged) was performed on the unknown lot # so the occurrence is unknown, the issue is unconfirmed and root cause can not be determined.Capa/sa: based on the above no additional investigation and no corrective or preventative action (capa) or situational analysis (sa) are required at this time.Dhr review: no dhr review can be carried out for the lot number#: unknown.

Event Description

It was reported that 1 bd intima ii¿ iv catheter prn adapter had catheter tubing damage.The following information was provided by the initial reporter, translated from chinese to english: it was reported by the customer that when using the closed vein indwelling needle on (b)(6) 2022, the patient found that the catheter tube was damaged and the closed vein indwelling needle was replaced in time.

• Brand Name: BD INTIMA II¿ IV CATHETER PRN ADAPTER
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14987985
• MDR Text Key: 303924803
• Report Number: 3014704491-2022-00270
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/11/2022

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 Catalogue Number: 383012
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 07/12/2022
• 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