MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 388423

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the bd insyte" iv catheter tip was found damaged before use.The following information was provided by the initial reporter, translated from (b)(6) to english: "the customer reported about catheter tip integrity.Before use in the operation room on october 15, a doctor found the damaged tip of the catheter.".

Manufacturer Narrative

Correction: the customer sent a photo showing the needle through the catheter prior to insertion within the unit packaging.This renders the device unusable and is not considered to be a reportable malfunction.

Event Description

It was reported that the bd insyte¿ iv catheter tip was found damaged before use.The following information was provided by the initial reporter, translated from japanese to english: "the customer reported about catheter tip integrity.Before use in the operation room on october 15, a doctor found the damaged tip of the catheter.".

• Brand Name: BD INSYTE IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10841546
• MDR Text Key: 217712781
• Report Number: 8041187-2020-00748
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 388423
• Device Lot Number: 9238444
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1