MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN S/L CATHETERS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0600040
Medical Device Problem Codes	Fluid/Blood Leak (1250); Failure to Infuse (2340)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0600040 chronic catheter allegedly experienced subcutaneous leak without embolization and failure to infuse.This information was received from one source.This malfunction involved one patient with no consequences.The patient's age, weight and gender were not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0600040 chronic catheter allegedly experienced subcutaneous leak without embolization and failure to infuse.This information was received from one source.This malfunction involved one patient with no consequences.The patient's age, weight and gender were not provided.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The device and one electronic photo has been returned to the manufacturer for evaluation.The investigation confirmed for burst and leak, however, unconfirmed for failure to infuse.As per the photo review, damage could not be observed.The issue was determined to be use related.The device is labeled for single use.H10: device code (1074 - burst container or vessel and 1601 - stretched) h10:g4 h11: h2, h6 (results and conclusion) 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.

• Brand Name: HICKMAN S/L CATHETERS
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9586490
• Report Number: 3006260740-2020-00051
• Device Sequence Number: 19438840
• Product Code: LJS
• UDI-Device Identifier: 00801741036309
• UDI-Public: (01)00801741036309
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2020

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: No Information
• Device Model Number: 0600040
• Device Catalogue Number: 0600040
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 04/01/2020
• Patient Sequence Number: 1