MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PowerLine CV Catheter, Polyurethane Dual-Lumen, 6F; Chronic Catheters

Catalog Number	0700615
Medical Device Problem Codes	Peeled/Delaminated (1454); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to a chronic catheter placement procedure, the package allegedly had a hole.It was further reported that the packaging was not sterile and could not be used.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.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 package allegedly had a hole.It was further reported that the packaging was not sterile and could not be used.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was returned for evaluation.Two photos were provided for review.Visual evaluation was performed on the returned sample.The top tyvek label was noted to be partially peeled halfway through the outer package.Partial seal transfer was noted along the top border of the outer product tray.An upper layer of the inner tyvek label was noted to be partially peeled from the product tray.The rest of the tyvek label was still attached to the product tray.Components were not noted to move freely within the product tray and did not appear affected.The manufacturing site review states, visual inspection of the images showed one partially sealed 6f powerline d/l catheter, it was observed that the lids of both trays were partially detached, it was observed that the outer tray lid had been opened properly while the inner tray lid was partially torn, a small hole was observed in the internal lid.Therefore, the investigation is confirmed for the reported tear, rip or hole in device issue.The definitive root cause could not be determined based upon available information.It is unknown whether shipping, handling, and storage factors contributed to the event.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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
A patient underwent catheter procedure using powerline central venous catheter.It was reported that prior to the placement procedure, the package allegedly had a hole.It was further reported that the packaging was not sterile and could not be used.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one partially sealed 6f powerline d/l catheter was received for evaluation and two electronic photos were provided for review.The first photo shows a partially peeled tray in which the inner layer is noted to be partially peeled and the inner components are visible.The peeling extends across a substantial portion of the lidstock, while the remaining portion remains attached to the tray.The second photo shows the product package in which product details was mentioned and verified with tw details.Gross visual evaluation was performed on the returned sample.The top tyvek label was noted to be partially peeled halfway through the outer package.Partial seal transfer was noted along the top border of the outer product tray.An upper layer of the inner tyvek label was noted to be partially peeled from the product tray.The rest of the tyvek label was still attached to the product tray.Components were not noted to move freely within the product tray and did not appear affected.The manufacturing site review states, visual inspection of the images showed one partially sealed 6f powerline d/l catheter, it was observed that the lids of both trays were partially detached, it was observed that the outer tray lid had been opened properly while the inner tray lid was partially torn, a small hole was observed in the internal lid, it was observed that the lid did not detach properly leaving an appearance of delamination, the components inside appeared to be clean and did not appear to present any problems.Therefore, the investigation is confirmed for the reported tear, rip or hole in device packaging and identified peeled/delaminated issues.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B5, g2, g3, h6 (device, result, conclusion).Section a through f: the information provide 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.

• Brand Name: PowerLine CV Catheter, Polyurethane Dual-Lumen, 6F
• 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 21281527
• Report Number: 3006260740-2025-00220
• Device Sequence Number: 13144068
• Product Code: LJS
• UDI-Device Identifier: 00801741036606
• UDI-Public: (01)00801741036606(11)240410(17)270731(10)REJP3943
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 09/15/2026

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: REJP3943
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/24/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: 06/27/2025; 09/14/2026
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 07/02/2025; 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2024
• 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