MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2 CATHETER W/ (TLS) STYLET 4F W/ MICROINTRODUCER (SL); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

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	08/01/2023
Type of Reportable Event	Malfunction
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 device has not been returned to the manufacturer for evaluation.H3 other text : device not returned for evaluation.
Event or Problem Description
It was reported by customer that after clear fluid noted in drug when picc flushed, approximately 7-8cm there is a small pinhole in the picc line.This would have been approximately 3-4 cm from the insertion pit/fit under the skin.
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 manufacturer has received the sample and is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported by customer that after clear fluid noted in drug when picc flushed, approximately 7-8cm there is a small pinhole in the picc line.This would have been approximately 3-4 cm from the insertion pit/fit under the skin.
Event or Problem Description
It was reported by customer that after clear fluid noted in drug when picc flushed, approximately 7-8cm there is a small pinhole in the picc line.This would have been approximately 3-4 cm from the insertion site under the skin.
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 complaint of a leaking catheter is confirmed and was determined to be use-related.One 4 fr s/l powerpicc was returned for evaluation.A functional test of attempting to pressurize the returned powerpicc with water using a 12 ml syringe revealed a leak just proximal of the 7 cm depth marker at the observed kink in the catheter.A microscopic observation revealed a longitudinally aligned split along the extrusion line of the catheter.A granular fracture surface was observed.The catheter wall thickness was measured near the fracture site and found to be within manufacturing specifications.Because the fracture was observed at the defined kink near the insertion site of the catheter, the complaint is confirmed and was determined to be caused by sharp kinking of the indwelling catheter shaft.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC SOLO2 CATHETER W/ (TLS) STYLET 4F W/ MICROINTRODUCER (SL)
• 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: 17597536
• Report Number: 3006260740-2023-03631
• Device Sequence Number: 6430169
• Product Code: LJS
• UDI-Device Identifier: 00801741028618
• UDI-Public: (01)00801741028618
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2024

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 Expiration Date: 08/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 9194118
• Device Lot Number: REGW3489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 01/18/2024; 01/29/2024
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 01/24/2024; 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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