MAUDE Adverse Event Report: TELEFLEX MEDICAL VASCULAR POSITIONING SYSTEM; CATHETER, ULTRASOUND, INTRAVASCULAR

Catalog Number VPS-G4C

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No sample will be returned for evaluation.

Event Description

It was reported the catheter was placed into the patient with the use of vps.The clinician had good p-wave and strong doppler and a blue bullseye was received.After the line was in place for sometime the patient needed an x-ray.The x-ray showed the picc was not in the proper location for a blue bullseye.There was no patient death or complications reported.The case was already deleted from the vps console.The customer would not share the x-ray showing where the catheter tip was located.No additional information is available.

Manufacturer Narrative

(b)(4).Device evaluation: the report a blue bullseye was received but an x-ray showed the picc was not in the proper location was not confirmed or reproduced evaluation of the returned sample.One sample (console unit gb40520 and accessories) was returned for evaluation.A vps service engineer conducted the evaluation.The visual evaluation determined the returned unit was in good condition.The unit was subjected to vps g4 console power-on test.The results of the test were acceptable indicating the unit was performing as intended.The reported event cannot be confirmed because all data was removed from the console prior to it being returned.The reported event cannot be reproduced because it is not the type of event that can be reproduced in the vps service lab.A device history record review for unit gb40520 was performed and no evidence was found to indicate a manufacturing related cause.The probable cause of this event could not be determined because no data was on the sample that was returned for evaluation.No further action will be taken.

• Brand Name: VASCULAR POSITIONING SYSTEM
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): TELEFLEX MEDICAL; tecate
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 5733245
• MDR Text Key: 47674312
• Report Number: 3003898360-2016-00680
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123813
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VPS-G4C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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