MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO FT CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5F; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported the clinician reported that the magnetic portion of the sherlock tip location system was failing, resulting in a misrepresentation of the catheter tip location.The clinician reported the 3cg portion of the sherlock, in her opinion, seems to be functioning appropriately, resulting in a maximally heighten p wave, as well as a diamond response from the system.The clinician sent over a screenshot from the sr8.See attachment.Upon examination of the ekg strip, the intrinsic ekg coming from the distal portion of the stylet appears to be highlighted green over the qrs complex as opposed to the p wave.When compared with the external ekg, the ¿un-heightened¿ p waves on the intrinsic wire correlated with the p waves on the external leads.Otherwise, myself, and the clinician can see and un-heightened p wave and a qrs complex that appear to be highlighted green, indicating diamond placement, followed by a t wave.The depth finder was given a response of mid depth.Due to the report, concerns, and questionable ecg reading, the clinician was advised to perform a chest x-ray.The chest x-ray showed a left-sided approached picc line with the distal tip at or near the svc/r atrial junction, indicating a perfect placement.The clinician did report that she felt as though this was happening more on the double lumen picc lines as opposed to the other picc lines being placed.She also thinks that the lot number for those particular picc lines had changed recently, and it is her opinion that, these issues started around the same time she noticed the lot numbers change.The clinician also reported that this happens on both sr8 machines as well as both sherlock chest plate devices.
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 is confirmed but the cause is unknown.The improper location of the lollipop could be due to magnetic interference (e.G.Headphones, call button, cell phone, etc.) or improper calibration.The improper highlighting of the waveform cause is unknown; possible contributing factors could include the software version or machine settings (both of which are unknown).In addition, it is unknown if this screenshot was taken right at final confirmation or if it was taken at a different time during the procedure.The depth indicator was circled in the photograph.It is unknown why this was circled.It is possible that the user was misinterpreting this as the depth in the svc rather than the distance anterior/posterior with relation to the sensor.The clinical specialist spent some time with the account and said he believes it was likely due to individual error h3 other text : evaluation findings are in section h11.
Event or Problem Description
It was reported the clinician reported that the magnetic portion of the sherlock tip location system was failing, resulting in a misrepresentation of the catheter tip location.The clinician reported the 3cg portion of the sherlock, in her opinion, seems to be functioning appropriately, resulting in a maximally heighten p wave, as well as a diamond response from the system.The clinician sent over a screenshot from the sr8.See attachment.Upon examination of the ekg strip, the intrinsic ekg coming from the distal portion of the stylet appears to be highlighted green over the qrs complex as opposed to the p wave.When compared with the external ekg, the ¿un-heightened¿ p waves on the intrinsic wire correlated with the p waves on the external leads.Otherwise, myself, and the clinician can see and un-heightened p wave and a qrs complex that appear to be highlighted green, indicating diamond placement, followed by a t wave.The depth finder was given a response of mid depth.Due to the report, concerns, and questionable ecg reading, the clinician was advised to perform a chest x-ray.The chest x-ray showed a left-sided approached picc line with the distal tip at or near the svc/r atrial junction, indicating a perfect placement.The clinician did report that she felt as though this was happening more on the double lumen picc lines as opposed to the other picc lines being placed.She also thinks that the lot number for those particular picc lines had changed recently, and it is her opinion that, these issues started around the same time she noticed the lot numbers change.The clinician also reported that this happens on both sr8 machines as well as both sherlock chest plate devices.

• Brand Name: POWERPICC SOLO FT CATHETER WITH SHERLOCK 3CG (TPS) STYLET 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16713073
• Report Number: 3006260740-2023-01262
• Device Sequence Number: 15269913
• Product Code: LJS
• UDI-Device Identifier: 00801741034626
• UDI-Public: (01)00801741034626
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023

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: 1295108FD
• Device Lot Number: REGW3725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 09/28/2023
• 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