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

Catalog Number UNK POWERLINE

Device Problems Suction Problem (2170); Malposition of Device (2616); Deformation Due to Compressive Stress (2889)

Patient Problem Pain (1994)

Event Date 01/06/2021

Event Type  Injury  

Event Description

It was reported through the results of a clinical trial, approximately one day post catheter placement, the subject developed adverse event of neck pain.It was further reported that the catheter was kinked, malpositioned and had suction issue.The catheter was removed and exchanged.The current status of the patient is unknown.

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not 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.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.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, kink, suction problem and neck pain issue.According to the clinical safety specialist report, one day post catheter implantation, the patient presented with an adverse event of neck pain and recovered.The adverse event of neck pain caused by kink in catheter.Repositioning of catheter was performed.Two days later, the device failure was noted post index procedure during indwelling.Interval repositioning of right internal jugular venous catheter which acutely kinked in the superior vena cava and extends into the neck through the internal jugular vein.After three days, there were product related technical difficulties experienced during indwelling time that repositioning occurred.Subsequently four days later, during blood withdrawal, the subject was noted malpositioned central line and having difficulty in getting blood return without several position changes and manipulation.Eventually, premature catheter removal was scheduled due to adverse event.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.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.H3 other text : device not returned.

Event Description

It was reported through the results of a clinical trial, approximately one day post catheter placement, the subject developed adverse event of neck pain.It was further reported that the catheter was kinked, malpositioned and had suction issue.The catheter was removed and exchanged.The current status of the patient is unknown.

• Brand Name: POWERLINE
• 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: 14186577
• MDR Text Key: 289867562
• Report Number: 3006260740-2022-01404
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• 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: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK POWERLINE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2022
• 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 Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White