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

Catalog Number 383722

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 10/25/2018

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It was reported that a bd pegasus¿ safety closed iv catheter system w/prn had a needle that couldn't be withdrawn and the safety shield failed to activate.There was no report of exposure, serious injury, or medical intervention.

Event Description

It was reported that a bd pegasus¿ safety closed iv catheter system w/prn had a needle that couldn't be withdrawn and the safety shield failed to activate.There was no report of exposure, serious injury, or medical intervention.

Manufacturer Narrative

Investigation summary: it was determined that this is the only instance of a safety shield failure occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections of packaged goods.Bd engineers were able to observe a tilted v-clip during the visual observation of the device.The root cause for this occurrence is the design of this component.Since the manufacture of this lot bd has optimized the design to prevent events such as this from occurring in the future.Investigation conclusion: bd engineers were able to observe a tilted v-clip during the visual observation of the device.In-activation of complaint failure mode caused by the tilted v-clip.Root cause description: the root cause for this occurrence is the design of this component.Since the manufacture of this lot bd has optimized the design to prevent events such as this from occurring in the future.

• Brand Name: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM W/PRN
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8057379
• MDR Text Key: 126924129
• Report Number: 8041187-2018-00410
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903837229
• UDI-Public: 382903837229
• 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: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 383722
• Device Lot Number: 7017020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Date Manufacturer Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other