MAUDE Adverse Event Report: BARD POWERGLIDE PRO MIDLINE CATHETER

Model Number 20G 10CM

Device Problem Break (1069)

Patient Problems Abscess (1690); Laceration(s) (1946); Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/10/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, patient had diagnostic laparoscopy, open cholecystectomy for gangrenous cholecystitis and drainage and washout of peritoneal bilious abscess.Post-operatively, picc team consulted for antibiotics.Per occurrence report documentation: powerglide placed to left brachial vein.When flushed noted saline leaking outside.Attempted to remove catheter, broke off.Vascular surgery was consulted.Per surgeon notes: the catheter had broken at the level of the brachial vein.Cxr and us of the ark demonstrated that the catheter had remained around 9.5 cm in the brachial axillary vein.Pt was taken emergently to the operating room for brachial vein exploration and removal of foreign material.An investigation was conducted on (b)(6) 2022, the picc team nurses were interviewed as well as the house supervisor and the patient.There were no insertion deviations from practice noted during the placement of the line.

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): BARD; salt lake city UT
• MDR Report Key: 16024119
• MDR Text Key: 305921882
• Report Number: 16024119
• Device Sequence Number: 1
• Product Code: PND
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 20G 10CM
• Device Lot Number: REGV1333
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White