MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SOFT-CELL PC-2 DIALYSIS CATHETER KIT 12.5F X 19 CM (PRE-CURVED) (LONG-TERM) (DL); BLOOD ACCESS AND ACCESSORIES

Model Number	5534190
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rebt1203 showed no other similar product complaint(s) from this lot number.Device not returned at this time.
Event or Problem Description
It was reported that after completing the placement procedure of the device, the healthcare professional (hcp) failed to aspirate blood.Therefore, the hcp suspected occlusion of the device and removed it from the patient.A new device was placed, that was used by another manufacturer.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint that the catheter caused the reported inability to aspirate blood after placement was unconfirmed because the problem could not be replicated.The implicated and returned product was a 19cm pre-curved soft-cell catheter.Residue was found within the fibers of the surecuff.A functional test of the catheter showed that both the arterial and venous lumens could be flushed and aspirated without and observed restriction or complication.With water in the lumen, the distal tip of the catheter was clamped closed and the syringe plunger was held down to create a positive pressure within the soft-cell catheter, but no leaks were observed in either lumen.The syringe plunger was retracted, which created a vacuum within the catheter, but no air was aspirated into the syringe.No problems with the catheter were observed.Clinical conditions such as catheter tip position and kinking may have been a contributing factor to the reported event and may have affected the functional performance of the returned device.No further action is required because the complainant event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of rebt1203 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that after completing the placement procedure of the device, the healthcare professional (hcp) failed to aspirate blood.Therefore, the hcp suspected occlusion of the device and removed it from the patient.A new device was placed, that was used by another manufacturer.

• Brand Name: SOFT-CELL PC-2 DIALYSIS CATHETER KIT 12.5F X 19 CM (PRE-CURVED) (LONG-TERM) (DL)
• Common Device Name: BLOOD ACCESS AND ACCESSORIES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7121363
• Report Number: 3006260740-2017-02242
• Device Sequence Number: 19188311
• Product Code: LFJ
• UDI-Device Identifier: 00801741012440
• UDI-Public: (01)00801741012440
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K871488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2018

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: 5534190
• Device Catalogue Number: 5534190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1