MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 4F DLMBPLUS (3CG); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A batch history review (bhr) of regw0951 showed no other similar product complaint(s) from this batch number.
Event or Problem Description
It was reported by the customer "(b)(6) 2023 called to assess patient lua dl picc, due to occlusion and positional since last night, seen by vat rn, noted with brisk blood return on both lumen, dressing is intact no visible kink, cpn and iv fluids flowing very good when arm is abduct and adduct , but when ask patient to raised his arm above his head , iv pump started to beep and occlusion detected, possible catheter issue as seen in cxr ,about 7-8 cm above the site noted intra lumen (possible kink/line fracture)." no other information was provided.
Event or Problem Description
It was reported by the customer "on (b)(6) 2023 called to assess patient lua dl picc, due to occlusion and positional since last night, seen by vat rn, noted with brisk blood return on both lumen, dressing is intact no visible kink, cpn and iv fluids flowing very good when arm is abduct and adduct , but when ask patient to raised his arm above his head , iv pump started to beep and occlusion detected, possible catheter issue as seen in cxr ,about 7-8 cm above the site noted intra lumen (possible kink/line fracture)." no other information was provided.Additional information received 2/28/2023: it was reported by the customer "catheter was secured with securacath.".
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.
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 kinked catheter was confirmed but the cause is unknown.Two ap radiographs of the left side of the chest and the arm were returned for evaluation of this complaint.The implicated product was a 4fr d/l powerpicc provena catheter.The left-sided picc was visible in the images.The catheter was seen overlapping itself at the insertion site into the skin and vein.The overlapping portion likely represented a kink in the line.However, a kink could not be confirmed with certainty without a 90-degree image to the current image to evaluate the overlapping section in the antecubital fossa.As the images likely showed a kink and the event description of positional occlusion are consistent with a kink, this complaint will be confirmed but the exact cause is not determined possible contributing factors could include the angle of the catheter as it entered the vein, catheter placement, or catheter securement.The ifu states, ¿avoid placement or securement of the catheter where kinking may occur, to minimize stress on the catheter, patency problems or patient discomfort.¿ and ¿avoid sharp or acute angles during implantation which could compromise the patency of the catheter lumen.¿ the report of a kinked catheter has been documented and will be monitored as part of complaint trending.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported by the customer "(b)(6) 2023 called to assess patient lua dl picc, due to occlusion and positional since last night, seen by vat rn, noted with brisk blood return on both lumen, dressing is intact no visible kink, cpn and iv fluids flowing very good when arm is abduct and adduct , but when ask patient to raised his arm above his head , iv pump started to beep and occlusion detected, possible catheter issue as seen in cxr ,about 7-8 cm above the site noted intra lumen (possible kink/line fracture)." no other information was provided.Additional information received 2/28/2023: it was reported by the customer "catheter was secured with securacath.".
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 "1/1/23 called to assess patient lua dl picc, due to occlusion and positional since last night, seen by vat rn, noted with brisk blood return on both lumen, dressing is intact no visible kink, cpn and iv fluids flowing very good when arm is abduct and adduct , but when ask patient to raised his arm above his head , iv pump started to beep and occlusion detected, possible catheter issue as seen in cxr ,about 7-8 cm above the site noted intra lumen (possible kink/line fracture)." no other information was provided.Additional information received on 2/28/2023: it was reported by the customer "catheter was secured with securacath." additional information received on 5/25/2023: catheter inserted 12cm above the antecubital fossa and 4cm left external to the patient.

• Brand Name: POWERPICC PROVENA 4F DLMBPLUS (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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16461257
• Report Number: 3006260740-2023-00594
• Device Sequence Number: 15096359
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/25/2023

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: S1274108D1
• Device Lot Number: REGW0951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2023
• 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; 05/17/2023; 05/25/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 03/27/2023; 05/23/2023; 05/26/2023
• 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 Age: 67 YR
• Patient Sex: Unknown
• Patient Weight: 85 KG