MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLINE 6FR DUAL LUMEN; CHRONIC CATHETERS

Catalog Number	0700615
Medical Device Problem Codes	Component Missing (2306); Device Markings/Labelling Problem (2911); Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that prior to a chronic catheter placement procedure, the catheter allegedly received with no label and expiration date.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: one sealed 6f powerline d/l catheter kit was received for evaluation and one electronic photo was provided for review.Upon visual evaluation, the product tyvek label was noted to be missing from the top of the package.Manufacturing site evaluation states that the product tyvek label was noted to be missing from the top of the package.An initial view showed a sealed package, the front of the outer packaging was observed, and the unit label was not present, no tears or significant damage were observed on the front of the packaging, the back of the packaging showed a literature kit attached to the transparent part of the tray.Therefore, the investigation is confirmed for the reported device markings/labelling issue.The definitive root cause could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: g3, h6 (method) h11: e1, h6 (result, conclusion) h11: section a through f ¿ the information provided by bd represents all 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.
Event or Problem Description
It was reported that prior to a chronic catheter placement procedure, the catheter allegedly received with no label and expiration date.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: one sealed 6f powerline d/l catheter kit was received for evaluation and one electronic photo was provided for review.Upon visual evaluation, the product tyvek label was noted to be missing from the top of the package.Manufacturing site evaluation states that the product tyvek label was noted to be missing from the top of the package.An initial view showed a sealed package, the front of the outer packaging was observed, and the unit label was not present, no tears or significant damage were observed on the front of the packaging, the back of the packaging showed a literature kit attached to the transparent part of the tray.Therefore, the investigation is confirmed for the reported device markings/ labelling issue.The definitive root cause was determined to be manufacturing related.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.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.
Event or Problem Description
It was reported that prior to a chronic catheter placement procedure, the catheter allegedly received with no label and expiration date.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: one sealed 6f powerline d/l catheter kit was received for evaluation and one electronic photo was provided for review.Upon visual evaluation, the product tyvek label was noted to be missing from the top of the package.Manufacturing site evaluation states that the product tyvek label was noted to be missing from the top of the package.An initial view showed a sealed package, the front of the outer packaging was observed, and the unit label was not present, no tears or significant damage were observed on the front of the packaging, the back of the packaging showed a literature kit attached to the transparent part of the tray.Therefore, the investigation is confirmed for the reported no label on outer package issue.The definitive root cause was determined to be manufacturing related.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: g3.H11: h6 (device).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.
Event or Problem Description
It was reported that prior to a chronic catheter placement procedure, the catheter allegedly received with no label and expiration date.The procedure was completed using another device.There was no patient contact.

• Brand Name: POWERLINE 6FR DUAL LUMEN
• Common Device Name: CHRONIC CATHETERS
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 20170724
• Report Number: 3006260740-2024-05073
• Device Sequence Number: 8250312
• Product Code: LJS
• UDI-Device Identifier: 00801741036606
• UDI-Public: (01)00801741036606
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K051417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0700615
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 10/24/2024; 03/07/2025; 05/29/2025
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 11/18/2024; 03/12/2025; 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown