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

Catalog Number 383914

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (b)(6).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 pegasus¿ safety closed iv catheter system malfunctioned on the third day as "nurse found septum pushed into adapter when changed infusion solution." there was no report of exposure, injury or medical intervention needed.

Event Description

It was reported that during use a bd pegasus¿ safety closed iv catheter system malfunctioned on the third day as "nurse found septum pushed into adapter when changed infusion solution." there was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

Conclusion(s): a complaint history check was not performed as this is the 1st related complaint reported with the defect/condition of septum pushed into adapter (q-syte) with lot #7324088 regarding item #383914.Na.The root cause was user.Conclusion(s): user: the unit demonstrated pattern markings opposite each other at the bottom body which are evidenc of the use of some type of pinchng/clamping object or instrument.Conclusion(s): indeterminate - a definite source that contributed to the septum top disk being pushed into the top body could not be established.This type of damage is normally attributed to incorrect usage or excessive actuations and/or extraneous force.There was no physical/mechanical evidence to confirm or support manufacturing process related issues for the defect as the unit demonstrated to have evidence of residual septum material and adhesive deposits on rim of the top body & top disk which were indicative of an adequate bond at time of manufacture.An instruction pamphlet is provided with q-syte product.This information documents the potential failure modes of this device if not used properly.

• Brand Name: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7621575
• MDR Text Key: 112061442
• Report Number: 8041187-2018-00203
• 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: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 12/23/2020
• Device Catalogue Number: 383914
• Device Lot Number: 7324088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Date Manufacturer Received: 05/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other