MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLINE CV CATHETER, POLYURETHANE TRIPLE-LUMEN, 6F; CHRONIC CATHETERS

Catalog Number	0730615
Medical Device Problem Codes	Failure to Disconnect (2541); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that sometime post a chronic catheter placement via the left subclavian vein, during the routine needle-free connectors change, clamps were needed to be placed directly on the colored plastic parts of the catheter to remove the connectors, which allegedly resulted in a stripping damage to the colored plastic pieces.It was further reported that needle-free connectors would not loosen without a clamp on the needle-free connectors and on the colored plastic piece of the catheter and turning the clamps in opposite directions.There was no reported patient injury.
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 not 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: 11/2026).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 sometime post a chronic catheter placement via the left subclavian vein, during the routine needle-free connectors change, clamps were needed to be placed directly on the colored plastic parts of the catheter to remove the connectors, which allegedly resulted in a stripping damage to the colored plastic pieces.It was further reported that needle-free connectors would not loosen without a clamp on the needle-free connectors and on the colored plastic piece of the catheter and turning the clamps in opposite directions.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the sample was not returned for evaluation.One electronic photo was provided for review.The photo shows the partial view of powerline catheter legs and physician holding both powerline connector.The visible scratch can be seen on both the items however as per allegation while removing the connectors, which allegedly resulted in a stripping damage.No failure to disconnect was observed.Therefore, based on the investigation and photo review, the reported failure to disconnect and scratched issue could be not confirmed as provided photos are not sufficient to confirm the issue.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.H10: d4 (expiration date: 11/2026), g3, h6 (method) h11: 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.H3 other text : device not returned.

• Brand Name: POWERLINE CV CATHETER, POLYURETHANE TRIPLE-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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18361911
• Report Number: 3006260740-2023-05770
• Device Sequence Number: 7743000
• Product Code: LJS
• UDI-Device Identifier: 00801741036637
• UDI-Public: (01)00801741036637
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K093927
• 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): 02/18/2024

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: 0730615
• Device Lot Number: REGZ1267
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 02/18/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 8 YR
• Patient Sex: Female
• Patient Weight: 30 KG
• Patient Ethnicity: Hispanic