MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INTIMA II¿ IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Defective Component (2292)

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

Event Date 11/30/2022

Event Type  malfunction  

Event Description

It was reported that the unspecified bd intima ii¿ iv catheter tubing clamp was defective during the infusion.The following information was provided by the initial reporter, translated from chinese: "at around 11:00 am on (b)(6) 2022, the patient was hospitalized for acute secretory otitis media.He followed the doctor's advice to prepare for the patient's indwelling needle infusion treatment.During the infusion, it was found that the indwelling needle tube clamp could not be clamped effectively, and the indwelling needle was replaced immediately to continue the infusion treatment.".

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Manufacturer Narrative

H6: investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.  the lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.

Event Description

It was reported that the unspecified bd intima ii¿ iv catheter tubing clamp was defective during the infusion.The following information was provided by the initial reporter, translated from chinese: "at around 11:00 am on november 30, 2022, the patient was hospitalized for acute secretory otitis media.He followed the doctor's advice to prepare for the patient's indwelling needle infusion treatment.During the infusion, it was found that the indwelling needle tube clamp could not be clamped effectively, and the indwelling needle was replaced immediately to continue the infusion treatment.".

• Brand Name: UNSPECIFIED BD INTIMA II¿ IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16079375
• MDR Text Key: 306832300
• Report Number: 2243072-2022-02256
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNKNOWN
• 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,Followup
• Report Date: 01/11/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 01/30/2023
• 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