MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA SLIM-CATH DIALYSIS 12F X 185CM DL SHORT-TERM; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number	5553150
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of redu3446 showed two similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the connection between the infusion tubing and scalp needle leaked water when conducting infusion for bed 10 patient in the afternoon.An inspection showed a small damage with the connector.The problem was resolved after the infusion sets were replaced.No other information was provided.
Event or Problem Description
It was reported that the connection between the infusion tubing and scalp needle leaked water when conducting infusion for bed 10 patient in the afternoon.An inspection showed a small damage with the connector.The problem was resolved after the infusion sets were replaced.No other information was provided.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd 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 bd.The device has not been returned to the manufacturer for evaluation.

• Brand Name: NIAGARA SLIM-CATH DIALYSIS 12F X 185CM DL SHORT-TERM
• Common Device Name: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12278534
• Report Number: 3006260740-2021-03151
• Device Sequence Number: 4599418
• Product Code: MPB
• UDI-Device Identifier: 00801741045356
• UDI-Public: (01)00801741045356
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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: 5553150
• Device Catalogue Number: 5553150
• Device Lot Number: REDU3446
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/14/2021
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 10/05/2021
• 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