MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN 10F TRIPLE-LUMEN CV CATHETER WITH SURECUFF TISSUE INGROWTH CUFF; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	0606460
Medical Device Problem Codes	Break (1069); Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2018
Type of Reportable Event	Malfunction
Additional 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 is pending return 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 or Problem Description
It was reported that the catheter has an alleged split that was found during use.There was no patient injury reported.
Event or Problem Description
It was reported that the catheter has an alleged split that was found during use.There was no patient injury reported.
Additional 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.This is the only complaint reported to date for this lot number and failure mode.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.Investigation summary: one 10 fr t/l hickman cv catheter.It was noted that the white-hub extension leg had a longitudinal s-shaped split in its lumen just proximal to the trifurcation.When the split was viewed under magnification, it was noted that the split had a granular surface near the center of the split and a smoother surface with striations towards the ends.The white-hub extension leg was noted to be occluded distal to the trifurcation before and after decontamination, with leaking observed from the split site.The other extension legs were both patent to infusion and aspiration with no leaks observed.Based on the findings associated with the identified split, the investigation is confirmed for the reported leak, specifically an external leak due to a burst.Per the evaluation results, the split site was longitudinal, s-shaped and had a granular surface.These are characteristics typical of a burst due to over-pressurization.Additionally, it was noted that the lumen was occluded distal to the trifurcation.Therefore, it is possible that over-pressurization due to flushing against an occlusion contributed to the reported event.However, the definitive root cause could not be determined based upon available information.

• Brand Name: HICKMAN 10F TRIPLE-LUMEN CV CATHETER WITH SURECUFF TISSUE INGROWTH CUFF
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7535742
• Report Number: 3006260740-2018-01043
• Device Sequence Number: 19245666
• Product Code: LJS
• UDI-Device Identifier: 00801741052002
• UDI-Public: (01)00801741052002
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2019

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 Model Number: 0606460
• Device Catalogue Number: 0606460
• Device Lot Number: HUBR1642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 02/03/2019
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1