MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN TRIFUSION CV CATHETER, TRIPLE-LUMEN, 12F; CHRONIC CATHETERS

Model Number 0609230

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 10/21/2020

Event Type  Injury  

Event Description

It was reported that approximately six months ten days post chronic catheter placement, the patient was diagnosed with bacteremia, which resulted in hospitalization.It was further reported that the patient was treated with antibiotics and catheter was removed.The event was possibly related to the procedure and study device.The current status of the patient is unknown.

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 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.Expiry date: 08/2021.Device not returned.

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 bacterial infection issue.According to the clinical safety specialist report, approximately six months post catheter deployment, the subject had an adverse event that admitted primarily due to sepsis from stenotrophomonas maltophili bacteremia suspected secondary to tunneled vascular catheter.The adverse event meets the definition of serious and prolongs the hospitalization period.Subsequently, the subject presented for retrieval of the catheter.The tunneled line removed, and antibiotic therapy was prolonged.The catheter exchange was not performed and removed without complication.The adverse event was possibly related to the procedure and study device.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 that approximately six months ten days post chronic catheter placement procedure, the patient was diagnosed with bacteremia, which resulted in hospitalization.It was further reported that the patient was treated with antibiotics and catheter was removed.The event was possibly related to the procedure and study device.The current status of the patient is unknown.

• Brand Name: HICKMAN TRIFUSION CV CATHETER, TRIPLE-LUMEN, 12F
• 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: 14158344
• MDR Text Key: 289599745
• Report Number: 3006260740-2022-01363
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741036538
• UDI-Public: (01)00801741036538
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0609230
• Device Catalogue Number: 0609230
• Device Lot Number: REDW3565
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/24/2022
• Initial Date FDA Received: 04/20/2022
• Supplement Dates Manufacturer Received: 05/13/2022
• Supplement Dates FDA Received: 05/19/2022
• 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): Hospitalization
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White