MAUDE Adverse Event Report: BD (SUZHOU) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM 24G X 0.75IN.; INTRAVASCULAR CATHETER

Catalog Number 383912

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 09/11/2017

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the safety mechanism on a bd pegasus" safety closed iv catheter system 24g x 0.75in.Failed to function properly during use.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation: a sample was received and decontaminated by eo.The returned sample cannot be successfully activated causing the cannula tip to be exposed, because the washer is missing.A review of the device history record revealed no irregularities during the manufacture of the reported lot numbers.A manufacturing review revealed that current assembly processes from the pegasus auto line only checks the presence before assembling, after which we found the washer has a low probability of popping out.The (b)(4) plant did complete a project on sept 30, 2017 to solve this problem.In conclusion, the complaint failure mode was caused by the missing washer when assembled.This failure has been resolved with the project completed on sept 3, 2017.

• Brand Name: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM 24G X 0.75IN.
• Type of Device: INTRAVASCULAR 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: 6925682
• MDR Text Key: 89159798
• Report Number: 3006948883-2017-00069
• 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: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 383912
• Device Lot Number: 7109222
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2017
• 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