MAUDE Adverse Event Report: BD (SUZHOU) BD PEGASUS¿ BL; INTRAVASCULAR CATHETER

Catalog Number 383932

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2018

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 with the use of the bd pegasus¿ bl there was an issue with safety shield activation failure.There was no report of injury or further medical intervention.

Manufacturer Narrative

Correction: 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.Investigation summary: the batch record for cat #383932 was reviewed, no related abnormalities were found during the manufacturing process.After reviewing dhr no abnormality was found in incoming inspection, whole assembly process and qa inspection.Lot # 6048448 manufactured on 03/24/2016 to 03/29/2016.A sample and photograph was received for the purpose of our investigation.Bd investigators were able to observe the reported failure mode in the sample provided, review of the device determined that the v-clip was tilted preventing the activation of the safety mechanism.The root cause of this event is a believed by bd engineers to be related to the design of the v-clip, which has undergone a redesign as of october 2017 to mitigate the possibility of occurrence for this issue.Bd will continue to track and trend for this issue.

Event Description

Correction: 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 investigation summary: the batch record for lot#383932 was reviewed, no related abnormalities were found during the manufacturing process.A sample and photograph was received for the purpose of our investigation.Bd investigators were able to observe the reported failure mode in the sample provided, review of the device determined that the v-clip was tilted preventing the activation of the safety mechanism.The root cause of this event is a believed by bd engineers to be related to the design of the v-clip, which has undergone a redesign as of october 2017 to mitigate the possibility of occurrence for this issue.Bd will continue to track and trend for this issue.

• Brand Name: BD PEGASUS¿ BL
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 7747818
• MDR Text Key: 116104621
• Report Number: 3006948883-2018-00137
• 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: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 383932
• Device Lot Number: 6048448
• Date Manufacturer Received: 07/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other