MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2 HF CATHETER WITH SHERLOCK 3CG TIP POSITIONING; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that "issue with ecg wire, clear stylet connection with beige port leaking saline when flushed when picc line in patient and issues pulling back blood return when ecg wire in place through beige stylet seems to let air in.Have to then disconnect flush and expel air and reconnect it and pull back to assess for blood return." additional info received on 13-july-23 customer reported that "the patient was in icu in central access.They had issues with the ecg wire being already bent inside the new picc, along plunger on the clear ecg wire housing spraying out once flushes while new picc in introducer well as pulling air as there doesn¿t seem to be a good seal with the change in the beige plunge.The event delayed them from being able to corr blood from red lumen once picc was placed.The wire bumping as we are pulling it in and out of trim it etc.Slow me down as patient was critically ill.She was also in rapid afib requiring a cxr tip location so that was also a delay that couldn¿t be avoided.".
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.
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 t-lock assembly was confirmed.The sample was evaluated and this event was determined to be related to a manufacture condition.Bd is working to prevent future occurrences of similar events and values your support and partnership in communicating this event and coordinating the return of the sample.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported by the customer that "issue with ecg wire, clear stylet connection with beige port leaking saline when flushed when picc line in patient and issues pulling back blood return when ecg wire in place through beige stylet seems to let air in.Have to then disconnect flush and expel air and reconnect it and pull back to assess for blood return." additional info received on 13-july-23.Customer reported that "the patient was in icu in central access.They had issues with the ecg wire being already bent inside the new picc, along plunger on the clear ecg wire housing spraying out once flushes while new picc in introducer well as pulling air as there doesn¿t seem to be a good seal with the change in the beige plunge.The event delayed them from being able to corr blood from red lumen once picc was placed.The wire bumping as we are pulling it in and out of trim it etc.Slow me down as patient was critically ill.She was also in rapid afib requiring a cxr tip location so that was also a delay that couldn¿t be avoided.".

• Brand Name: POWERPICC SOLO2 HF CATHETER WITH SHERLOCK 3CG TIP POSITIONING
• 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 bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17399042
• Report Number: 3006260740-2023-03197
• Device Sequence Number: 20721915
• Product Code: LJS
• UDI-Device Identifier: 00801741091292
• UDI-Public: (01)00801741091292
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2023

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: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: CK000394
• Device Lot Number: REGX2175
• 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: 07/07/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• 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 Age: 65 YR
• Patient Sex: Female