MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM; N/A

Catalog Number 383712

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 03/18/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd pegasus¿ safety closed iv catheter system prn was loose.This was discovered during use.The following information was provided by the initial reporter: the patient had effusion in the chest but had less coughing at night.The nurse sealing the tube, and found that the prn was loosen from adapter and missing after 45 minutes.Because the pp connector was connected with infusion pump, the clamp was not sealed, which caused blood leakage on patient and the blood wet two clothes.Lost prn not found on site.The nurse uses a syringe to connect the prn when sealing the tube, and holds the cap by hand to seal the tube.

Manufacturer Narrative

H.6 investigation summary : no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.

Event Description

It was reported that bd pegasus¿ safety closed iv catheter system prn was loose.This was discovered during use.The following information was provided by the initial reporter: the patient had effusion in the chest but had less coughing at night.The nurse sealing the tube, and found that the prn was loosen from adapter and missing after 45 minutes.Because the pp connector was connected with infusion pump, the clamp was not sealed, which caused blood leakage on patient and the blood wet two clothes.Lost prn not found on site.The nurse uses a syringe to connect the prn when sealing the tube, and holds the cap by hand to seal the tube.

• Brand Name: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
• Type of Device: N/A
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9937901
• MDR Text Key: 189477339
• Report Number: 8041187-2020-00200
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: PENDING
• 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: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 383712
• Device Lot Number: 9179841
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other