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

Model Number 381237

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

Patient Problem No Patient Involvement (2645)

Event Date 09/18/2020

Event Type  malfunction  

Manufacturer Narrative

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 foreign matter was found on the bd insyte¿ peripheral venous catheter hub before use.The following information was provided by the initial reporter, translated from (b)(6) to english: "when the nurse unwrapped the package and took out the product, she could see a small black spot on the hilt of the hub".

Event Description

It was reported that foreign matter was found on the bd insyte¿ peripheral venous catheter hub before use.The following information was provided by the initial reporter, translated from chinese to english: "when the nurse unwrapped the package and took out the product, she could see a small black spot on the hilt of the hub".

Manufacturer Narrative

H6: investigation summary a device history review was conducted for lot number 9298167.Our records show that this is the only instance of foreign matter occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Although photos were submitted for evaluation, the affected device is required for a more in depth analysis of the issue.Unfortunately, without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.See h.10.

• Brand Name: BD INSYTE PERIPHERAL VENOUS CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10774904
• MDR Text Key: 216124119
• Report Number: 8041187-2020-00705
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903812371
• UDI-Public: 30382903812371
• Combination Product (y/n): N
• PMA/PMN Number: K151698
• 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: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 381237
• Device Catalogue Number: 381237
• Device Lot Number: 9298167
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1