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

Catalog Number 383912

Device Problem Detachment Of Device Component (1104)

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

Event Date 05/22/2017

Event Type  malfunction  

Manufacturer Narrative

There is no 510(k) for this device as it is manufactured outside the us and not sold in the us.(b)(6).Results: two samples were returned for evaluation.A visual inspection revealed the samples were unused and in sealed packages.A simulated use test was conducted and the safety mechanisms of both units were activated successfully.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6231295.A manufacturing review revealed no abnormalities with incoming material, the assembly process, or the packaging process.Conclusion: an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.(b)(4).

Event Description

It was reported that after successful insertion of a bd pegasus¿ safety closed iv catheter system 24 g x 0.75 in., the safety shield separated from the needle.There was no injury or medical intervention reported in association with this reported defect.

• Brand Name: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM 24G X 0.75IN.
• 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: 6648666
• MDR Text Key: 78046265
• Report Number: 3006948883-2017-00019
• 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
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 383912
• Device Lot Number: 6231295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2016
• 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