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

Catalog Number UNKNOWN

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/10/2023

Event Type  malfunction  

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported that rust was found on a bent unspecified bd intima ii¿ iv catheter prn adapter needle core during use.The following information was provided by the initial reporter, translated from chinese to english: when a nurse performs intravenous infusion on a patient, she uses an indwelling needle.The indwelling needle is bent and rusty, so she needs to replace it promptly.

Manufacturer Narrative

A complaint history record(chr) review could not be performed as no material and batch/lot number was made available for this reported event.A device history record(dhr) review could not be performed as no material and batch/lot number was made available for this reported event.Based on limited information available after multiple unsuccessful attempts to obtain - unable to assess the rm documentation.A retain sample analysis cannot be performed as no material and batch/lot number was provided.Root cause couldn't be determined due to unavailability of sample, material and batch/lot number information.

Event Description

No additional information provided.

• Brand Name: UNSPECIFIED 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18446573
• MDR Text Key: 332143587
• Report Number: 3014704491-2023-00877
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNK
• 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: 01/29/2024

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: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 01/04/2024
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1