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

Catalog Number 383721

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 07/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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¿ iv catheter had safety shield activation failure.No serious injury or medical intervention was reported.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: yes.The batch record for lot#8044404 was reviewed, no related abnormalities were found during the manufacturing process.A sample was received for the purpose of our investigation.The investigators were unable to observe the reported failure mode in the sample provided, preventing bd engineers from finalizing the root cause for this event.However, historical data suggests that this event was potentially caused by the design of the safety mechanism.The design has since been optimized to mitigate the potential for similar events to occur in the future.Bd will continue to track and trend for this issue.

Event Description

It was reported that bd pegasus iv catheter had safety shield activation failure.No serious injury or medical intervention was reported.

• 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: 7752376
• MDR Text Key: 116613141
• Report Number: 8041187-2018-00276
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 383721
• Device Lot Number: 8044404
• Date Manufacturer Received: 07/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other