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

Catalog Number 383722

Device Problem Fail-Safe Design Failure (1222)

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

Event Date 03/28/2018

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 nurse found that the safety activation failed on a bd pegasus¿ safety closed iv catheter system w/prn during use.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Investigation summary: a photo was received for the purpose of our investigation.Bd was able to observe the reported failure mode in the sample provided.The supplied photograph shows that the v-clip was stuck in the tip shield, and that the v-clip was noticeably tilted.The tilted v-clip caused the inactivation of the unit.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 7054445.Investigation conclusion: the tilted v-clip caused the inactivation of the unit.Additionally our investigators have noted this lot was manufactured prior to a redesign was finalized that mitigates the occurrence of this type of failure mode.

• 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: 7444939
• MDR Text Key: 106161168
• Report Number: 8041187-2018-00101
• 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: 05/15/2018

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: 02/29/2020
• Device Catalogue Number: 383722
• Device Lot Number: 7054445
• Initial Date Manufacturer Received: 03/28/2018
• Initial Date FDA Received: 04/19/2018
• Supplement Dates Manufacturer Received: 03/28/2018
• Supplement Dates FDA Received: 05/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other