MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD POWERGLIDE PRO; DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Model Number N/A

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/01/2023

Event Type  Injury  

Event Description

It was reported, "facility uses powerglide pro midline catheters in its patients and in the medical department (md).On the 20th of this month, during the placement of one of these 22g caliber catheters, lot rehs3824, the tip of the guide wire broke off during its removal and became lodged in the subcutaneous tissue.It should be noted that the technique was carried out by a highly experienced nurse and went off without a hitch.The guide wire went perfectly, but the catheter ended up bending during insertion and when it was removed, the tip broke off and remained completely in the subcutaneous tissue for around 4cm.The incident compromised the patient's care and he was operated on by the surgical department with the need for local exploration, with an opening of around 1.5cm of the skin and subsequent suturing.The same situation had already occurred with another nurse.As the tip of the catheter was visualized, the nurse removed it with forceps.Without any other associated complications." it was reported this occurred with two devices.This report addresses the first device that required surgery to remove.

Manufacturer Narrative

H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The device has not been returned to the manufacturer for evaluation.H3 other text : device not returned for evaluation.

• Brand Name: BARD POWERGLIDE PRO
• Type of Device: DEVICE, INTRAVASCULAR CATHETER SECUREMENT
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19128023
• MDR Text Key: 340449173
• Report Number: 3006260740-2024-01844
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2024

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: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention