MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY 70 CM NITINOL GW; 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	01/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported two 5f dl radiology piccs have leaked at the casing on the purple hub.It was stated the devices were not used on patients.This report addresses the first device.
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refw4392 showed sixteen other similar product complaint(s) from this lot number.
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refw4392 showed sixteen other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported two 5f dl radiology piccs have leaked at the casing on the purple hub.It was stated the devices were not used on patients.This report addresses the first device.
Event or Problem Description
It was reported two 5f dl radiology piccs have leaked at the casing on the purple hub.It was stated the devices were not used on patients.This report addresses the first device.
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 leaking catheters was confirmed and the cause was manufacturing-related.The product returned for evaluation was two 5fr d/l powerpicc catheters.Both catheters were untrimmed.Light usage residues were observed.Attempts to infuse water through the samples using a 12ml syringe revealed all four lumens to be patent to infusion and aspiration; however, during pressurization of both samples, leaks were observed at the purple luer/syringe junctions.Inspection of the purple luers adapter using an iso taper gauge revealed that the gauge could not be fully inserted into the luer orifices.Microscopic inspection of the purple luer adapters revealed protrusions in the luer material within the orifices.The mold defects appeared to prevent firm attachment of the syringe, as well as full insertion of the taper gauge.The molding defect observed within the luer orifices prevented firm attachment with the syringes and resulted in leakage at the interface between the catheter and the syringe.Photographs of the sample have been forwarded to the manufacturing site for further evaluation.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY 70 CM NITINOL GW
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13602287
• Report Number: 3006260740-2022-00498
• Device Sequence Number: 5857332
• Product Code: LJS
• UDI-Device Identifier: 00801741027963
• UDI-Public: (01)00801741027963
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051672
• 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: 3275355
• Device Lot Number: REFW4392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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