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

Catalog Number 383083

Device Problems Unsealed Device Packaging (1444); Out-Of-Box Failure (2311)

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

Event Date 04/25/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that three bd intima ii¿ iv catheter packages were opened prior to use.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 batch record also was reviewed, no related abnormalities were found.The investigators noted that the packaging was torn alone the thin lidding that covers the pouch that contains the device.The most likely cause for this type of damage is the transportation and storage of the device.If the master case is squeezed or deformed, or if the packaging for the individual device is exposed to a large external force, the lidding of the packaging unit can be breached.

• 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: 7527466
• MDR Text Key: 108802652
• Report Number: 3006948883-2018-00065
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 07/23/2020
• Device Catalogue Number: 383083
• Device Lot Number: 7178388
• Date Manufacturer Received: 04/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other