MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLINE CV CATHETER, POLYURETHANE SINGLE-LUMEN, 5F; CHRONIC CATHETERS

Catalog Number	0700515
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being 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.H10: d4 (expiration date: 03/2028).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 during preparation for a chronic catheter placement procedure, received a box of powerlines and external packaging was allegedly found to be damaged.It was further reported that the labels on the outside of the packaging were allegedly not sticking and it easily fell off.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: one sealed 5f powerline s/l catheter kit in its original packaging was retuned for sample evaluation.Along with return sample one photo was provided for review.Visual evaluation was performed.The product tyvek labels were noted to be detached throughout the outer packaging; they were received taped onto the top package label.Loss of bond and labelling issue were noted in the photo review.Manufacturing review was performed and ¿label on outside of the packaging were allegedly not sticking and it easily fell off¿ was verified.The product unit label was observed to be folded into the outer packaging lid, the tear-off labels were taped together, an apparently incidental break was observed on the tear-off labels.The back (transparent) of the tray showed the components inside and components were not affected.Therefore, the investigation is confirmed for the reported failure to bond and labelling 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.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 during preparation for a chronic catheter placement procedure, received a box of powerlines and external packaging was allegedly found to be damaged.It was further reported that the labels on the outside of the packaging were allegedly not sticking and it easily fell off.There was no patient contact.

• Brand Name: POWERLINE CV CATHETER, POLYURETHANE SINGLE-LUMEN, 5F
• 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: 19571422
• Report Number: 3006260740-2024-03177
• Device Sequence Number: 3980569
• Product Code: LJS
• UDI-Device Identifier: 00801741036583
• UDI-Public: (01)00801741036583(11)240209(17)280331(10)REHZ1509
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K050185
• 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
• Report Date (Section B): 11/08/2024

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: 0700515
• Device Lot Number: REHZ1509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2024
• 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