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

Catalog Number 381234

Device Problem Retraction Problem (1536)

Patient Problems Hematoma (1884); Discomfort (2330)

Event Date 01/25/2018

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.

Event Description

It was reported that during use, a bd insyte¿ iv catheter malfunctioned as ¿the catheter retracts along the needle when being inserted into the vein.This is the second time that this incident occurred, hematoma and discomfort for the patient as a 2nd point of puncture was necessary.Additional invasive procedure resulting in delay in patient management.There was no report of medical intervention.

Manufacturer Narrative

Investigation summary: the nonconformance cannot be confirmed as no sample was returned for investigation.The complaint will be reopened if the sample is returned for investigation.A review of the device history record revealed no irregularities during the manufacture of the reported lot number.Investigation conclusion: the root cause cannot be determined as no samples were returned for investigation.

• Brand Name: BD INSYTE¿ IV CATHETER
• Type of Device: IV CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7310099
• MDR Text Key: 101626693
• Report Number: 8041187-2018-00039
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903812340
• UDI-Public: 30382903812340
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 381234
• Device Lot Number: 7139066
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other