MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER-TRIALYSIS SHORT-TERM STRAIGHT 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	08/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the catheter is faulty (drug leakage).No other information was provided.
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
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 following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a catheter leak could not be confirmed due to poor sample condition.One photo sample of a 24 cm trialysis catheter was provided for evaluation.The photo shows the extension legs and proximal portion of the catheter.Blood residue is present within the device.The presence of damage or leak location could not be clearly determined from the image provided.Based on the description of the reported event, possible contributing factors include sharp instrument damage and catheter damage during use.Since the reported issue could not be confirmed from the image provided, the complaint remains inconclusive at this time.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported the catheter is faulty (drug leakage).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 following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking catheter was confirmed.The product returned for evaluation was one 24cm powertrialysis t/l dialysis catheter.Usage residues were observed throughout the sample.An attempt to infuse water through the sample using a 12ml syringe revealed all three lumens to be patent to infusion; however, when flushing the purple-luered lumen, a spraying leak was observed just distal of the molded joint.Microscopic inspection of the leak site revealed a v-shaped split.The split exhibited sharply defined features.The fracture edges exhibited a glossy texture.The fracture features were consistent with damage caused by contact between the catheter and a traumatic instrument, such as a needle tip.The blood residue suggested that contact occurred during device use.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported the catheter is faulty (drug leakage).No other information was provided.

• Brand Name: POWER-TRIALYSIS SHORT-TERM STRAIGHT 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15328040
• Report Number: 3006260740-2022-03407
• Device Sequence Number: 5287619
• Product Code: NIE
• UDI-Device Identifier: 00801741041914
• UDI-Public: (01)00801741041914
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 12/12/2022

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 Model Number: N/A
• Device Catalogue Number: 5608240
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2022
• Supplement Date Received by Manufacturer: 09/27/2022; 12/12/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 09/30/2022; 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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