MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported "we had an issue with a powerglide.When the nurse advanced the catheter into the patient one part of the device slid with it to the end of the needle.It was stated the part at the end with blood in it shouldn¿t haven¿t moved all the way to the end of the needle.We took apart the device to be sure and found the guidewire and needle were intact." add info rcvd 10/12/2020: when the nurse placed the powerglide, as she slid the catheter into the vessel over the needle and guidewire, the portion of the device-directly behind the hub of the catheter, that typically slides to the end of the needle and then locks, slid further over the guidewire.All parts of the needle and guidewire were intact.No harm to the patient.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a defective powerglide pro assembly was inconclusive due to the nature of the returned sample.The product returned for evaluation was one photograph depicting two 18ga powerglide pro midline catheter assemblies.Both devices exhibited advanced catheters and activated safety mechanisms.The device on the left was assembled and appeared unremarkable.The device on the right was fully disassembled, with the needle completely removed from the housing.Details about the devices were not discernible in the photograph.No damage or defect was observed during examination of the submitted photograph; however, the implicated device could not be thoroughly assessed.Consequently this complaint is inconclusive at this time.

Event Description

It was reported "we had an issue with a powerglide.When the nurse advanced the catheter into the patient one part of the device slid with it to the end of the needle.I it was stated the part at the end with blood in it shouldn¿t haven¿t moved all the way to the end of the needle.We took apart the device to be sure and found the guidewire and needle were intact." add info rcvd 10/12/2020: when the nurse placed the powerglide, as she slid the catheter into the vessel over the needle and guidewire, the portion of the device-directly behind the hub of the catheter, that typically slides to the end of the needle and then locks, slid further over the guidewire.All parts of the needle and guidewire were intact.No harm to the patient.

• Brand Name: POWERGLIDE CATHETER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10708288
• MDR Text Key: 213660570
• Report Number: 3006260740-2020-20190
• Device Sequence Number: 1
• Product Code: FOX
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2020
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other