MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICK 9.6FR S/L CATH W/VITA; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number	0600630
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review 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 approximately seven weeks after the placement of the chronic catheter via the left subclavian vein, the health care provider decided to remove the chronic catheter due to the completion of the treatment.It was further reported that during the device removal procedure, the health care provider allegedly finds resistance while pulling the catheter, however, when the catheter was finally released the cuff was detached from the catheter and retained in the patient.Reportedly, the patient experienced discomfort from pulling the catheter, however, the patient reported to be in the stable condition after the device removal procedure.
Event or Problem Description
It was reported that approximately seven weeks after the placement of the chronic catheter via the left subclavian vein, the health care provider decided to remove the chronic catheter due to the completion of the treatment.It was further reported that during the device removal procedure, the health care provider allegedly finds resistance while pulling the catheter, however, when the catheter was finally released the cuff was detached from the catheter and retained in the patient.Reportedly, the patient experienced discomfort from pulling the catheter, however, the patient reported to be in the stable condition after the device removal procedure.
Additional Manufacturer Narrative
Manufacturer review: a lot history record could not be completed as the lot number was not provided.Investigation summary: a sample evaluation could not be performed as the samples were not returned.The investigation is inconclusive for cuff detachment.A definitive root cause could not be determined.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.Pma/510k.
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review 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 approximately seven weeks after the placement of the chronic catheter via the left subclavian vein, the health care provider decided to remove the chronic catheter due to the completion of the treatment.It was further reported that during the device removal procedure, the health care provider allegedly finds resistance while pulling the catheter, however, when the catheter was finally released the cuff was detached from the catheter and retained in the patient.Reportedly, the patient experienced discomfort from pulling the catheter, however, the patient reported to be in the stable condition after the device removal procedure.

• Brand Name: HICK 9.6FR S/L CATH W/VITA
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8870798
• Report Number: 3006260740-2019-02321
• Device Sequence Number: 3079440
• Product Code: LJS
• UDI-Device Identifier: 00801741051944
• UDI-Public: (01)00801741051944
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2019

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: 0600630
• Device Catalogue Number: 0600564
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 11/13/2019; 12/19/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 11/19/2019; 12/20/2019
• 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