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

Catalog Number 383714

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2017

Event Type  malfunction  

Manufacturer Narrative

Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.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 shield failed to separate on a bd pegasus¿ safety closed iv catheter system 24g x 0.75in.Catheter hub while withdrawing the needle.There was no report of injury or medical intervention.

Manufacturer Narrative

Samples were received and decontaminated.The returned material showed the reported defect.No retention samples were received.Dhr revealed on lot 7017500 revealed no abnormalities found in the incoming material and the whole assembly process and qa inspection.The specifications of the complaint batch is 24g.No abnormality was found in the incoming material, the whole assembly process and packing process.According to the returned information, successfully punctured, safety shield failed to separate from the catheter hub during needle withdrew.Returned sample showed the tip shield are connected to the catheter adapter indeed and v-clip tilt.Simulation of the device revealed when the v-clip was lightly touched to reset, v-clip successfully activated.The pegasus current production process, when the technician maintains the machine of assembly v-clip.It maybe the gripper extrude the v-clip.The 100% online visual inspection can find this kind of detection, the machine can eliminate the defect sample, so the defection maybe flow to subsequent process of the assembly.The product was not within specification.V-clip tilt caused stuck in tip, which can¿t be activated.No capa initiated.Bd was able to duplicate or confirm the customer¿s indicated failure.

• 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: 6876252
• MDR Text Key: 87633923
• Report Number: 3006948883-2017-00066
• 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: 10/30/2017

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: Other
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 383714
• Device Lot Number: 7017500
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2017
• Initial Date FDA Received: 09/19/2017
• Supplement Dates Manufacturer Received: 08/22/2017
• Supplement Dates FDA Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2017
• 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