MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 4F DL MBPLUS (3CG); S1274108D1

Model Number	N/A
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A batch history review (bhr) of regv0508 showed 1 other similar product complaint(s) from this batch number.The complaints for this lot number (regv0508) have been reported from the same facility.
Event or Problem Description
It was reported by the customer that "no kink found but catheter replaced r/t multiple failed declot attempts.(b)(6) 2023 vat requested to troubleshoot pt's picc d/t lack of blood return in red lumen, unable to get to function appropriately despite several troubleshooting efforts.Surgery messaged via corus'd to recommend new picc placement as picc line has had >10 doses of alteplase since 1/1/2023.Picc removed and replaced.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 difficulty infusing through the catheter was inconclusive due to the sample condition.A single ap chest radiograph, that was coned down to the right side and included the right arm, was returned for evaluation.The implicated product was a 4fr d/l powerpicc provena catheter.The right-sided picc appeared to be free of kinks, loops, and coils.The tip location of the catheter could not be determined as the grainy image made it difficult to evaluate.Functional testing, dimensional analysis, and visual observation of the device could not be conducted without receipt of the physical sample.As the submitted radiographic image did not contain enough information to confirm the event or identify a specific root cause, this complaint will be recorded as inconclusive at this time.A review of the manufacture quality and inspection records for the specific lot involved found no potentially related issues encountered during the manufacture and assembly of that product lot.Potential causes for difficulty infusing through the catheter could include precipitate formation in the catheter lumen, a buildup of biological material, or catheter collapse.H3 other text: evaluation findings are in section h11.
Event or Problem Description
It was reported by the customer that "no kink found but catheter replaced r/t multiple failed declot attempts.(b)(6) 2023 vat requested to troubleshoot pt's picc d/t lack of blood return in red lumen, unable to get to function appropriately despite several troubleshooting efforts.Surgery messaged via corus'd to recommend new picc placement as picc line has had >10 doses of alteplase since (b)(6) 2023.Picc removed and replaced." additional information received on 2/28/2023: catheter was secured with securacath.Patient being treated for a gunshot wound.
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 by the customer that "no kink found but catheter replaced r/t multiple failed declot attempts.On (b)(6) 2023 vat requested to troubleshoot pt's picc d/t lack of blood return in red lumen, unable to get to function appropriately despite several troubleshooting efforts.Surgery messaged via corus'd to recommend new picc placement as picc line has had >10 doses of alteplase since (b)(6) 2023.Picc removed and replaced.Additional information received on 2/28/2023: catheter was secured with securacath.Patient being treated for a gunshot wound.

• Brand Name: POWERPICC PROVENA 4F DL MBPLUS (3CG)
• Common Device Name: S1274108D1
• 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: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16483089
• Report Number: 3006260740-2023-00672
• Device Sequence Number: 15371538
• Product Code: LJS
• UDI-Device Identifier: 00801741154744
• UDI-Public: (01)00801741154744
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2023

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: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: S1274108D1
• Device Lot Number: REGV0508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2023
• Supplement Date Received by Manufacturer: 02/28/2023; 05/18/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 04/01/2023; 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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: 21 YR
• Patient Sex: Male
• Patient Weight: 101 KG