MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SOFT-CELL PC DIALYSIS CATHETER KIT 12.5F X 19 CM (PRE-CURVED) (LONG-TERM); CATHETER, SUBCLAVIAN

Model Number	5533190
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records could not be performed.The device is pending return to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard 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 bard.
Event or Problem Description
It was reported that there was an alleged tear in the tunneler prior to patient use.However, the healthcare professional used the device and allegedly the size of the tear increased.The procedure was completed successfully.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: neither a lot history review nor a device history records (dhr) review could be performed as the lot number was not provided.Investigation summary: one tunneler was returned for evaluation.Visual and microscopic evaluations were performed.The investigation is confirmed for a damaged tunneler as multiple parallel tears were found at one end of the plastic tunneler sheath.There was some scratching around the splits.The break surfaces of the tears appeared to have more damage near the surface of the sheath.The root cause of the event is unknown as it is not known where or how this damage occurred.However, externally-originating damage from a tool or sharp instrument is possible.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.
Event or Problem Description
It was reported that there was an alleged tear in the tunneler prior to patient use.However, the healthcare professional used the device and allegedly the size of the tear increased.The procedure was completed successfully.There was no reported patient injury.

• Brand Name: SOFT-CELL PC DIALYSIS CATHETER KIT 12.5F X 19 CM (PRE-CURVED) (LONG-TERM)
• Common Device Name: CATHETER, SUBCLAVIAN
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7720314
• Report Number: 3006260740-2018-01837
• Device Sequence Number: 1015319
• Product Code: LFJ
• UDI-Device Identifier: 00801741012396
• UDI-Public: (01)00801741012396
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K030277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2019

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: 5533190
• Device Catalogue Number: 5533190
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 01/12/2019
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1