MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER-TRIALYSIS SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by healthcare professional that the hub leaked air and blood.This happened despite their standard practice of flushing out clots mid procedure; nothing unusual, nothing aggressive.The leak only came to their knowledge when they kept aspirating air while performing a femoral venous puncture ¿ once the needle goes in and they start to aspirate, immediately air is aspirated, recurrently.Leading to the patient poked many times, as they kept thinking connection is loose.But that¿s not the case.And after that ¿ they tried to flush, and the hub leaked blood and saline.Patient status/intervention : patient is fine.Changed new set.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refq4323 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by healthcare professional that the hub leaked air and blood.This happened despite their standard practice of flushing out clots mid procedure; nothing unusual, nothing aggressive.The leak only came to their knowledge when they kept aspirating air while performing a femoral venous puncture ¿ once the needle goes in and they start to aspirate, immediately air is aspirated, recurrently.Leading to the patient poked many times, as they kept thinking connection is loose.But that¿s not the case.And after that ¿ they tried to flush, and the hub leaked blood and saline.Patient status/intervention : patient is fine.Changed new set.
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 initial complaint appeared to be a reportable occurrence.Upon review of the complaint, it was determined that a reportable event had not occurred.

• Brand Name: POWER-TRIALYSIS SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15122475
• Report Number: 3006260740-2022-02920
• Device Sequence Number: 12173914
• Product Code: NIE
• UDI-Device Identifier: 00801741042003
• UDI-Public: (01)00801741042003
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2022

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 Expiration Date: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 5618240
• Device Lot Number: REFQ4323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown