MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY; 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	01/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "noting two 5f dl radiology piccs have leaked at the casing on the purple hub." no other information was provided.This report addresses the first device.
Additional Manufacturer Narrative
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 luer connection was confirmed and the cause appeared to be manufacturing related.The product returned for evaluation was one 5fr d/l powerpicc catheter.Light usage residues were observed.An attempt to infuse water through the sample using a 12ml syringe revealed both lumens to be patent to infusion; whoever, during pressurization, leakage was observed at the interface between the syringe and the purple luer adapter.Microscopic inspection of the purple luer adapter revealed deformation along the inner edge of the orifice.Inspection of the luer adapters using an iso taper gauge revealed the purple luer to be below minimum specifications.The leakage at the syringe/luer interface was caused by the luer orifice being too small.It appeared that the luer was formed out of specifications during the molding/curing process.Photographs have been forwarded to the manufacturing site for further evaluation.A lot history review (lhr) of refv2167 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (refv2167) have been reported from the same facility.
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 luer connection was confirmed and the cause appeared to be manufacturing related.The product returned for evaluation was one 5fr d/l powerpicc catheter.Light usage residues were observed.An attempt to infuse water through the sample using a 12ml syringe revealed both lumens to be patent to infusion; whoever, during pressurization, leakage was observed at the interface between the syringe and the purple luer adapter.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.Inspection of the purple luer adapter using an iso taper gauge revealed that the gauge could not be fully inserted into the luer orifice.The molding defect observed within the luer orifice prevented firm attachment with the syringe 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.
Event or Problem Description
It was reported "noting two 5f dl radiology piccs have leaked at the casing on the purple hub." no other information was provided.This report addresses the first device.

• Brand Name: POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13518488
• Report Number: 3006260740-2022-00299
• Device Sequence Number: 17470871
• 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: K051627
• 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: REFV2167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2021
• 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