MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT,4FR POWERMIDLINE; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redv4045 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported via ms&s "wife states her husband has powermidline p4154108d inserted on (b)(6) 2019 for antibiotics.She states while at a health facility last evening the cap of the powermidline came off and was no placed on the midline.She states she is concerned about the potential for bleeding and infection.She states she has taken her husband out of the facility and is going to see the physician today.She states the clamp is closed and the powermidline will be removed today.Ms&s informed her to make sure the clamp stays closed.Informed her that if the hub has been left exposed there would be an infection risk.".

• Brand Name: DOT,4FR POWERMIDLINE
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kayla olsen ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225010
• MDR Report Key: 9453562
• MDR Text Key: 170739865
• Report Number: 3006260740-2019-03813
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741108761
• UDI-Public: (01)00801741108761
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: P4154108D
• Device Lot Number: REDV4045
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Manufacturer Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2019
• 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