MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMO CATH & PIK; DIALYSIS CATHETER

Model Number	0600660
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number of the device was provided.The device history records are currently under review.The return of the sample is pending.The investigation is currently underway.(expiry date: 08/2021).
Event or Problem Description
It was reported approximately two weeks post placement that the dialysis catheter allegedly dislodged.It was further reported that the patient was hospitalized following removal and replacement of the device.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one d/l 13.5f catheter was returned for evaluation.Functional and gross visual evaluations were performed.The investigation is inconclusive for catheter dislodgement and for the cuff failing to adhere, as the exact circumstances at the time of the reported event are unknown and could not be reproduced in the lab.The sample appeared clean except for blood/tissue residue noted on the cuff.No anomalies were noted during sample evaluation.An attachable suture wing was not present on the catheter.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.(expiry date: 08/2021).
Event or Problem Description
It was reported approximately two weeks post placement that the dialysis catheter allegedly dislodged.It was further reported that the patient was hospitalized following removal and replacement of the device.

• Brand Name: HEMO CATH & PIK
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8604946
• Report Number: 3006260740-2019-01369
• Device Sequence Number: 3020333
• Product Code: LJS
• UDI-Device Identifier: 00801741037504
• UDI-Public: (01)00801741037504
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2019

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 Expiration Date: 08/31/2021
• Device Model Number: 0600660
• Device Catalogue Number: 0600660
• Device Lot Number: REBY1922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 07/09/2019
• 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: Hospitalization
• Patient Age: 58 YR