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

Catalog Number 388433

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2018

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 with the use of the bd insyte¿ iv catheter there was an issue with tip defect.There was no report of injury or further medical intervention.

Event Description

It was reported with the use of the bd insyte¿ iv catheter there was an issue with tip defect.There was no report of injury or further medical intervention.

Manufacturer Narrative

Investigation summary: the nonconformance cannot be confirmed as no actual sample was returned for investigation.Dhr review shows the packaged needle batch 7020231, catalogue number 388433 and its assembled needle batch 7020274 catalogue number 8301330 had no notifications for similar nonconformance during the production of the batch.The preventive maintenance, calibration and equipment history records were reviewed, no abnormality was found.No capa is required.The complaint will be reopened if the sample is returned for investigation.

Event Description

It was reported with the use of the bd insyte¿ iv catheter there was an issue with tip defect.There was no report of injury or further medical intervention.

• 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: 7704021
• MDR Text Key: 114802734
• Report Number: 8041187-2018-00242
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 388433
• Device Lot Number: 7020231
• Date Manufacturer Received: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other