MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN HEMODIALYSIS/APHERESIS CATHETER, DUAL-LUMEN,13.5F; DIALYSIS CATHETER

Model Number	0600660
Medical Device Problem Codes	Material Puncture/Hole (1504); Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history record could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that an attempt was made to pull back the blood on hickman catheter, blood was not returned.It was further reported that a hole was opened near a seam while attempted to flush the device at normal pressure.There was no 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 not returned to the manufacturer for evaluation.Therefore, the investigation is inconclusive for the reported no blood return and hole issue.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 provide by bd represents all 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.
Event or Problem Description
It was reported that an attempt was made to pull back the blood on hickman catheter, blood was not returned.It was further reported that a hole was opened near a seam while attempted to flush the device at normal pressure.There was no reported patient injury.

• Brand Name: HICKMAN HEMODIALYSIS/APHERESIS CATHETER, DUAL-LUMEN,13.5F
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10990770
• Report Number: 3006260740-2020-20847
• Device Sequence Number: 3823042
• Product Code: LJS
• UDI-Device Identifier: 00801741037504
• UDI-Public: (01)00801741037504
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2021

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: 0600660
• Device Catalogue Number: 0600660
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 05/22/2021
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 05/28/2021
• 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