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

Catalog Number 383083

Device Problem Scratched Material (3020)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that burrs were found on the catheter of a bd intima ii¿ iv catheter, when the nurse removed from the patient.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation summary: a sample was received for the purpose of our investigation.The investigators were able to observe the reported failure mode in the sample provided.The tip of the returned unit was damaged but review of the retention samples and batch paperwork could not yield insight into the potential cause of this defect.Unfortunately bd is unable to determine the root cause for this issue, but will continue to track and trend.The batch record also was reviewed, no related abnormalities were found.Investigation conclusion: the tip of the returned unit was damaged but review of the retention samples and batch paperwork could not yield insight into the potential cause of this defect.Unfortunately bd is unable to determine the root cause for this issue, but will continue to track and trend.

• Brand Name: BD INTIMA II¿ IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 7523135
• MDR Text Key: 108908604
• Report Number: 3006948883-2018-00064
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K100775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 11/09/2020
• Device Catalogue Number: 383083
• Device Lot Number: 7265043
• Date Manufacturer Received: 04/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other