MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICK 9.6FR S/L CATH; CHRONIC CATHETER

Model Number	0600160
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the five reported complaints, fives devices were returned for evaluation.Lot numbers were provided for two malfunctions and the remaining three lot numbers are unknown.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This report summarizes five malfunctions.A review of the reported information indicated that model 0600160 chronic catheter allegedly experienced defective components.These reports were received from various sources.All four events had no reported patient injury and one event had no reported patient contact.Age, weight, and gender were not provided for the patient.
Event or Problem Description
This report summarizes five malfunctions.A review of the reported information indicated that model 0600160 chronic catheter allegedly experienced defective components.These reports were received from various sources.Of the five malfunctions, one did not involve patients, and four involved patients with no reported patient injury.Age, weight, and gender were not provided for the patients.
Additional Manufacturer Narrative
H10: for the five reported complaints, fives devices were returned for evaluation.Lot numbers were provided for two out of the five malfunctions; therefore, a lot history review is currently being performed.Defective component was confirmed for two devices.For the three remaining devices, the company is still investigating the issue at this time.The definitive root cause is unknown.The device is labeled for single use.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.
Event or Problem Description
This report summarizes five malfunctions.A review of the reported information indicated that model 0600160 chronic catheter allegedly experienced defective components.These reports were received from various sources.Of the five malfunctions, one did not involve patients, and four involved patients with no reported patient injury.Age, weight, and gender were not provided for the patients.
Additional Manufacturer Narrative
H10: for the five reported complaints, five devices were returned for evaluation.Lot numbers were provided for two out of the five malfunctions; therefore, a lot history review was performed.Damaged cuff was confirmed for (b)(4) devices.Cuff detachment was confirmed for (b)(4) devices.Longitudinal and circumferential split and leak was confirmed for (b)(4) device.The definitive root cause is unknown.The device is labeled for single use.H10: g4 h11: g1, h6 (results, 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: HICK 9.6FR S/L CATH
• Common Device Name: CHRONIC CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9592298
• Report Number: 3006260740-2020-00095
• Device Sequence Number: 19625806
• Product Code: LJS
• UDI-Device Identifier: 00801741051722
• UDI-Public: (01)00801741051722
• 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,Followup
• Report Date (Section B): 07/01/2020

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: 0600160
• Device Catalogue Number: 0600160
• Device Lot Number: UNKNOWN, HUDQ2675
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/24/2020; 06/30/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 03/24/2020; 07/01/2020
• Patient Sequence Number: 1