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

Model Number	0600620
Medical Device Problem Codes	Burst Container or Vessel (1074); Obstruction of Flow (2423); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Fever (1858); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that the catheter was removed due to a split at the end of the lumen.There was reported patient injury.
Event or Problem Description
It was reported that sometime post port catheter implant, the device allegedly had an occlusion.It was further reported that, the tip was removed.There was reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the sample was returned to the manufacturer for evaluation and three electronic photos were provided for review.Gross, microscopic visual and functional testing were performed.The investigation is confirmed for the reported lumen burst as a c-shaped split was noted just distal to the y-body.Leaking was observed from the c-shaped split when infusing the white lumen, and blood residue was observed exiting from split when infusing the white lumen from the distal end.During infusion of the red lumen from the distal end, extreme residence was noted and brief catheter ballooning was observed before a rupture was observed just distal to the y-body.The rupture appeared to be an s-shaped split and was radially adjacent to the c-shaped split.Although resistance and catheter balloon was observed while infusing the red lumen and blood residue was noted exiting from the c-shaped split during infusion of the white lumen, the investigation is inconclusive for the reported catheter occlusion, as the exact circumstances at the time of the reported event are unknown.Based upon the available information a definitive root cause could not be determined.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 : see h10.

• Brand Name: HICKMAN CV CATHETER, DUAL-LUMEN,12F
• Common Device Name: CHRONIC CATHETERS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10703588
• Report Number: 3006260740-2020-20165
• Device Sequence Number: 2849400
• Product Code: LJS
• UDI-Device Identifier: 00801741051913
• UDI-Public: (01)00801741051913
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021

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
• Operator of Device: Health Professional
• Device Model Number: 0600620
• Device Catalogue Number: 0600620
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention