MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER WITH SHERLOCK TLS TECHNOLOGY 5F; 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	04/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported "it looks like we have another leaking 5fr.At the hub." 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 and the cause was manufacturing-related.The product returned for evaluation was one 5fr d/l powerpicc catheter.Light usage residues were observed throughout the sample and needleless injection caps were attached to the luer adapters.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion and aspiration; however, a leak was observed at the junction between the injection cap 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 cap, as well as full insertion of the taper gauge.A longitudinally aligned scoring mark was observed within the orifice adjacent to the mold defect.The molding defect observed within the purple luer orifice prevented firm attachment with the 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.
Event or Problem Description
It was reported "it looks like we have another leaking 5fr.At the hub." no other information was provided.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK TLS TECHNOLOGY 5F
• 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: 14306865
• Report Number: 3006260740-2022-01625
• Device Sequence Number: 14664388
• Product Code: LJS
• UDI-Device Identifier: 00801741035692
• UDI-Public: (01)00801741035692
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K063240
• 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): 09/27/2022

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: 9275108D
• 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: 04/15/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 09/30/2022
• 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