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

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	09/11/2024
Type of Reportable Event	Serious Injury
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 will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported that 3cg confirmed picc placement on 9/9.On 9/11, patient was having arrhythmias so cxr was ordered.On 9/11 radiologist states picc was long and had them pull picc back 9cms.Question is why did 3cg show it was good placement.At first this was just a simple education question, now the management is questioning weather 3cg is accurate and reliable.Additional info: patient having arrhythmia after picc placed which was confirmed by 3cg.Cxr completed and picc was malpositioned in the r atrium.It was determined additional 3cg education should be provided along with landmark measuring techniques.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.
Event or Problem Description
It was reported that 3cg confirmed picc placement on (b)(6).On (b)(6), patient was having arrhythmias so cxr was ordered.On (b)(6) radiologist states picc was long and had them pull picc back 9cms.Question is why did 3cg show it was good placement.At first this was just a simple education question, now the management is questioning weather 3cg is accurate and reliable.Additional info: patient having arrhythmia after picc placed which was confirmed by 3cg.Cxr completed and picc was malpositioned in the r atrium.It was determined additional 3cg education should be provided along with landmark measuring techniques.No other information was provided.
Event or Problem Description
It was reported that 3cg confirmed picc placement on (b)(6).On (b)(6), patient was having arrhythmias so cxr was ordered.On (b)(6) radiologist states picc was long and had them pull picc back 9cms.Question is why did 3cg show it was good placement.At first this was just a simple education question, now the management is questioning weather 3cg is accurate and reliable.Additional info: patient having arrhythmia after picc placed which was confirmed by 3cg.Cxr completed and picc was malpositioned in the r atrium.It was determined additional 3cg education should be provided along with landmark measuring techniques.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 complaint of a malpositioned catheter is inconclusive due to the state of the returned sample.One photograph of an ecg printout was returned for evaluation.An initial visual observation of the photograph showed what appears to be a normal ecg as well as an ecg with an elevated p-wave.No negative p-waves were observed in the ecgs in the returned photograph.While the returned photograph shows an ecg with the expected waveform for good positioning of the catheter tip, it was not possible to confirm improper catheter tip placement from the returned photograph.It is possible that the stylet was not positioned properly within the catheter during placement, or that the catheter tubing repositioned after placement due to manipulation of the catheter or inadequate securement of the catheter.However, inspection of the returned photograph was insufficient to confirm a malpositioned catheter or determine the root cause of the reported event.Therefore, this complaint is inconclusive at this time.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC PROVENA, 3CG
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20418841
• Report Number: 3006260740-2024-05845
• Device Sequence Number: 8295673
• Product Code: LJS
• UDI-Device Identifier: 00801741154942
• UDI-Public: (01)00801741154942(11)240626(17)250930(10)REJS0081
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: N/A
• Device Catalogue Number: S1274108D3
• Device Lot Number: REJS0081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: 11/15/2024; 03/12/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 12/13/2024; 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• 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: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Unknown