MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DECATHLON DF LONG-TERM HEMODIALYSIS CATHETER; DECATHLON CATHETER

Model Number	DF19SH24K
Medical Device Problem Codes	Nonstandard Device (1420); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2020
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 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 (ifu) 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.
Event or Problem Description
It was reported that during a procedure, the device did not have a hole in it and guidewire was unable to advance the sheath.There was no reported patient injury.
Event or Problem Description
It was reported that during a procedure, the device did not have a hole in it and guidewire was unable to advance the sheath.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 device was not returned for evaluation.Therefore, the investigation is inconclusive for the reported absence of hole in dilator issue.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.H3 other text: device not returned.

• Brand Name: DECATHLON DF LONG-TERM HEMODIALYSIS CATHETER
• Common Device Name: DECATHLON CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10807352
• Report Number: 3006260740-2020-20430
• Device Sequence Number: 3525606
• Product Code: MSD
• UDI-Device Identifier: 00801741013942
• UDI-Public: (01)00801741013942
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K033294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2021

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: DF19SH24K
• Device Catalogue Number: DF19SH24K
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 04/13/2021
• 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