MAUDE Adverse Event Report: BD (SUZHOU) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM; INTERVASCULAR CATHETER

Catalog Number 383912

Device Problem Fail-Safe Design Failure (1222)

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

Event Date 11/22/2017

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 the bd pegasus¿ safety closed iv catheter system failed to fully retract when the safety mechanism was activated leaving the tip of the needle exposed.Found during use.No serious injury or medical intervention noted.

Manufacturer Narrative

Results - bd received one used sample.Visual inspection of the device confirmed the complaint.A review of the device history record revealed no irregularities during the manufacture of the reported lot.Conclusion - complaint confirmed, the malfunction was caused by the v-clip deformation.The suzhou plant is conducting tests to avoid this kind of failure in the future.

• Brand Name: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7119819
• MDR Text Key: 95074300
• Report Number: 3006948883-2017-00182
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 383912
• Device Lot Number: 7178104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other