MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NIAGARA SLIM-CATH DIALYSIS CATHETER KIT 12F X 24CM (STRAIGHT) (SHORT-TERM) (DUAL; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number	N/A
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recs2349 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that in the application, it would always bleed a lot from the puncture site and they could not stop the bleeding.Hcp says it would not be an user error but the dilatation catheter would be too big.Therefore catheter was removed and a new catheter was used (competitor product).
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 of bleeding at the puncture site was inconclusive since the complaint could not be confirmed from the returned sample.One sealed niagara slim cath catheter kit was returned for investigation.The kit was opened.No apparent issues were observed on the kit components.The diameter of the 13 fr dilator was measured at the largest diameter and was found to be within specification.Both catheter lumens were flushed with water using a 12 ml syringe and were found to be patent to infusion.Since no apparent issues were observed on the returned samples, the complaint could not be confirmed.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.
Event or Problem Description
It was reported that in the application, it would always bleed a lot from the puncture site and they could not stop the bleeding.Hcp says it would not be an user error but the dilatation catheter would be too big.Therefore catheter was removed and a new catheter was used (competitor product).

• Brand Name: NIAGARA SLIM-CATH DIALYSIS CATHETER KIT 12F X 24CM (STRAIGHT) (SHORT-TERM) (DUAL
• Common Device Name: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8414214
• Report Number: 3006260740-2019-00531
• Device Sequence Number: 389852
• Product Code: MPB
• UDI-Device Identifier: 00801741045370
• UDI-Public: (01)00801741045370
• Combination Product (Y/N): N
• PMA/510(K) Number: K010778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

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: N/A
• Device Catalogue Number: 5553240
• Device Lot Number: RECS2349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 04/11/2019
• 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: Required Intervention