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

Model Number 0700615

Device Problem Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/03/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiration date: 08/2024).

Event Description

It was reported through the results of a clinical trial, that post central venous catheter placement procedure, the device was allegedly malpositioned.It was further reported that the catheter was removed and exchanged.The current status of the patient is unknown.

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 clinical safety specialist report was provided for review.The investigation is confirmed for the reported catheter malposition issue.According to the clinical safety specialist report, approximately sometimes post catheter placement, the subject had a device failure post index procedure during indwelling that the right internal jugular central venous catheter was malpositioned.During drug administration, the catheter with tip likely within the left brachiocephalic/internal jugular vein.Three days later, premature catheter removal was scheduled due to adverse event.Subsequently, the catheter was removed without complication and catheter exchange was performed.A definitive root cause could not be determined based upon the available 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.D4 (expiry date: 08/2024).H11: 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.

Event Description

It was reported through the results of a clinical trial, that post central venous catheter placement procedure, the device was allegedly malpositioned.It was further reported that the catheter was removed and exchanged.The current status of the patient is unknown.

• Brand Name: POWERLINE DUAL-LUMEN, 6F
• Type of Device: 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: 14332448
• MDR Text Key: 291203755
• Report Number: 3006260740-2022-01697
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741036606
• UDI-Public: (01)00801741036606
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0700615
• Device Catalogue Number: 0700615
• Device Lot Number: REEZ2866
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American