MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN 12.5 FR TRIPLE-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUF; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 0600650

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 08/20/2018

Event Type  Injury  

Manufacturer Narrative

No medical records or medical images have been made available to the manufacturer.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.The investigation of the reported event is currently underway.The information provided by bard 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 bard.

Event Description

It was reported that the patient developed a blood stream infection.The infection was discovered with positive blood cultures.The patient was reported to have a fever and was hypotensive.The catheter was removed and replaced.The patient was prescribed micafungin for the infection.

Manufacturer Narrative

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 hickman 12.5f triple lumen catheter was returned for evaluation.A partial circumferential split was noted on the blue luer extension leg; this damage was reported with complaint (b)(4) and captured in the associated investigation.A complete circumferential break was noted approximately 20.1cm distal to the trifurcation, however the break surfaces were observed to possess the characteristics of a scissor cut and the break was likely to have been made intentionally after device removal to facilitate return of the device.The investigation is inconclusive for the reported infection as the original conditions of use could not be replicated and no medical records were provided for review.It is possible that the damage to the extension leg, reported and confirmed in conjunction with complaint (b)(4), contributed to the reported infection.However, the definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the reported event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(expiry date: 10/2022).

Event Description

It was reported that the patient developed a blood stream infection.The infection was discovered with positive blood cultures.The patient was reported to have a fever and was hypotensive.The catheter was removed and replaced.The patient was prescribed micafungin for the infection.

• Brand Name: HICKMAN 12.5 FR TRIPLE-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUF
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD SHANNON LIMITED; san geronimo industrial park; lot #1, road #3, km 79.7; humacao 00791
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7874193
• MDR Text Key: 120186522
• Report Number: 3006260740-2018-02451
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741051975
• UDI-Public: (01)00801741051975
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K830233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0600650
• Device Catalogue Number: 0600650
• Device Lot Number: HUCR0854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Date Manufacturer Received: 03/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2018
• 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: 69 YR