MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 4F SL POLYURETHANE RADIOLOGY BT 135 NITONOL GUIDEWIRE; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of refx0144 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "on 12/30/21, we placed a 4fr single lumen picc (ref (b)(4)) (lot#:refx0144) on a patient in the morning.Before end of day, we were asked to inspect this catheter for leakage.Upon investigation, the catheter was indeed leaking at the luer lock connection with the positive pressure cap.The cap was changed multiple times, with subsequent flushing producing the same result of leakage at the luer lock connection.The catheter was exchanged that day for a new one, different lot, with no further issues.No harm or injury was sustained by the patient.".
Additional Manufacturer Narrative
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 manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of refx0144 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "on (b)(6) 2021, we placed a 4fr single lumen picc (ref3174335) (lot#:refx0144) on a patient in the morning.Before end of day, we were asked to inspect this catheter for leakage.Upon investigation, the catheter was indeed leaking at the luer lock connection with the positive pressure cap.The cap was changed multiple times, with subsequent flushing producing the same result of leakage at the luer lock connection.The catheter was exchanged that day for a new one, different lot, with no further issues.No harm or injury was sustained by the patient.".
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 and the cause was manufacturing-related.The product returned for evaluation was one 4fr s/l powerpicc catheter.Usage residues were observed throughout the sample.A needleless injection cap was attached to the purple luer adapter.An attempt to infuse water through the sample using a 12ml syringe revealed the catheter to be patent to infusion; however, during pressurization, leakage was observed at the junction between the luer adapter and the needleless injection cap.Inspection of the purple luer adapter using an iso taper gauge revealed that the gauge could not be fully inserted into the luer orifice.Microscopic inspection of the purple luer adapter revealed a protrusion in the luer material within the orifice.The mold defect appeared to prevent firm attachment of the injection cap, as well as full insertion of the taper gauge.The molding defect observed within the luer orifice prevented firm attachment with the needleless injection cap and resulted in leakage at the interface between the catheter and the cap.Photographs of the sample have been forwarded to the manufacturing site for further evaluation.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "on (b)(6).2021, we placed a 4fr single lumen picc (ref (b)(4).) (lot# (b)(4).) on a patient in the morning.Before end of day, we were asked to inspect this catheter for leakage.Upon investigation, the catheter was indeed leaking at the luer lock connection with the positive pressure cap.The cap was changed multiple times, with subsequent flushing producing the same result of leakage at the luer lock connection.The catheter was exchanged that day for a new one, different lot, with no further issues.No harm or injury was sustained by the patient.".

• Brand Name: POWERPICC 4F SL POLYURETHANE RADIOLOGY BT 135 NITONOL GUIDEWIRE
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• 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: 13350600
• Report Number: 3006260740-2022-00055
• Device Sequence Number: 17389302
• Product Code: LJS
• UDI-Device Identifier: 00801741027628
• UDI-Public: (01)00801741027628
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

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: 3174335
• Device Lot Number: REFX0144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2022
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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