MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 5F DL POWERMIDLINE MAX KIT; MIDLINE CATHETER

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Foreign Body Embolism (4439)
Date of Event	01/23/2024
Type of Reportable Event	Serious Injury
Additional 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 received.
Event or Problem Description
It was reported that the patient required a midline iv to be placed by a qualified interventional radiology registered nurse, which reported to have been inserted with no issues.The patient¿s condition decompensated, and she required an intensive care consult with additional oxygen need and vasopressors.A ct (computerized tomography) of the chest/abdomen/pelvis without contrast was ordered.In the reading, there was noted to be a new \linear metallic density within the right and left pulmonary arteries, favored to represent a foreign body such as a catheter or guidewire fragment¿.A ct performed 3 days prior to the midline insertion did not show the foreign body.Additional information received 03/01/2024: it was reported the foreign material was never removed prior to expiration.We cannot confirm it had an effect on the outcome, only that it was identified on imaging.

• Brand Name: 5F DL POWERMIDLINE MAX KIT
• Common Device Name: 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18856495
• Report Number: 3006260740-2024-00948
• Device Sequence Number: 12835895
• Product Code: PND
• UDI-Device Identifier: 00801741129360
• UDI-Public: (01)00801741129360
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K162900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: N/A
• Device Catalogue Number: P4255108D
• Device Lot Number: REHT2959
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown