MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT, 4FR POWERMIDLINE; MIDLINE CATHETER

Catalog Number P4154108D

Device Problem Material Frayed (1262)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/18/2023

Event Type  Injury  

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.

Event Description

It was reported by customer that midline was placed in right brachial vein.Guidewire was retained, clinician did not realize, and they finalized insertion.Next day, line was not flushing, so removed line.Patient was discharged, following day patient went to outside hospital with complaint of arm pain and received an x-ray to determine there was a wire in the arm.Patient experienced arm pain a few days later and x-ray determined wire left in arm.Guidewire fractured to two pieces.One piece in forearm, one in neck.Went to or to have it removed.No other information provided.

• Brand Name: DOT, 4FR POWERMIDLINE
• Type of Device: MIDLINE CATHETER
• 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: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17671143
• MDR Text Key: 322516249
• Report Number: 3006260740-2023-03860
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: P4154108D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2023
• 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