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

Catalog Number 383721

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/02/2018

Event Type  malfunction  

Manufacturer Narrative

A sample is not available for evaluation.However, a no sample investigation and device history record review will be completed.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the safety device on a bd pegasus¿ safety closed iv catheter system failed to function correctly.There was no report of exposure, injury or medical interventions.

Manufacturer Narrative

Investigation results: a sample/photo was not received for the purpose of our investigation, the investigators were unable to observe the reported failure mode.The batch record was reviewed, no related abnormalities were found.Although the root cause could not be determined without evidentiary support, previous investigations into this issue have shown that the v-clip becomes inactivated as a result of an external force being applied to the safety mechanism during the withdrawal of the cannula.This leads to the offset of the v-clip and unable to activate under normal condition.

• Brand Name: BD PEGASUS¿ IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7371207
• MDR Text Key: 103660475
• Report Number: 8041187-2018-00078
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 383721
• Device Lot Number: 6295058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/13/2018
• Initial Date FDA Received: 03/26/2018
• Supplement Dates Manufacturer Received: 03/13/2018
• Supplement Dates FDA Received: 05/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other