MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE ST MIDLINE CATHETER FULL KIT (20G) (8CM); CATHETER,INTRAVASCULAR,THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redn1319 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that over the wire powerglide was inserted on patient in right upper arm in the er.Catheter kinked before leaving the patient's bedside.Unable to withdrawal blood.Had to reinsert different type of midline.

• Brand Name: POWERGLIDE ST MIDLINE CATHETER FULL KIT (20G) (8CM)
• 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: 9169969
• MDR Text Key: 161787446
• Report Number: 3006260740-2019-02950
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741139314
• UDI-Public: (01)00801741139314
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• 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: ST220081
• Device Lot Number: REDN1319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 09/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2019
• 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