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

Model Number	N/A
Medical Device Problem Codes	Failure to Infuse (2340); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The manufacturer has received the sample and is pending evaluation.Results are expected soon.A batch history review (bhr) of regr1787 showed no other similar product complaint(s) from this batch number.
Event or Problem Description
It was reported by the customer "12/22/2022 pt reported that her picc would occlude frequently and that she would have to adduct her right arm while keeping the palms up towards the ceiling.Dressing changed rn started ns bolus and no issues observed.12/29 reports picc occlusion issues.X-ray requested.Attempted pulling line back to eliminate loop x 2.Picc was removed on (b)(6) and new picc order placed." no other information was provided.
Event or Problem Description
It was reported by the customer "12/22/2022 pt reported that her picc would occlude frequently and that she would have to adduct her right arm while keeping the palms up towards the ceiling.Dressing changed rn started ns bolus and no issues observed.(b)(6) reports picc occlusion issues.X-ray requested.Attempted pulling line back to eliminate loop x 2.Picc was removed on (b)(6) and new picc order placed." no other information was provided.Additional information received 2/28/2023: catheter had been secured with securacath.
Event or Problem Description
It was reported by the customer "(b)(6) 2022 pt reported that her picc would occlude frequently and that she would have to adduct her right arm while keeping the palms up towards the ceiling.Dressing changed rn started ns bolus and no issues observed.(b)(6) reports picc occlusion issues.X-ray requested.Attempted pulling line back to eliminate loop x 2.Picc was removed on 1/6 and new picc order placed." no other information was provided.Additional information received (b)(6) 2023: catheter had been 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.The complaint of difficulty infusing through the catheter was confirmed but the exact cause is unknown.Three coned down radiographic images of the patient¿s right arm and the proximal portion of the picc were returned for evaluation of this complaint.The implicated product was a 4fr s/l powerpicc catheter.There was a loop and potentially a kink present in the catheter shaft.The loop appeared to be in the subcutaneous soft tissues and the possible kink was located at the entrance site into the vein.A compression securement device was seen in the images, proximal of the catheter loop and kink.It was reported that flow through the catheter was contingent upon the patient¿s arm position, indicating a positional occlusion.The occlusion was likely caused by the loop/kink in the catheter.Possible contributing factors could include the patient¿s anatomy (muscles and fascia), catheter placement, or catheter securement.Avoid placement or securement of the catheter where kinking may occur, to minimize stress on the catheter, patency problems or patient discomfort.The report of difficulty infusing the catheter, secondary to catheter kinking, 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 "on (b)(6) 2022 pt reported that her picc would occlude frequently and that she would have to adduct her right arm while keeping the palms up towards the ceiling.Dressing changed rn started ns bolus and no issues observed.On (b)(6), reports picc occlusion issues.X-ray requested.Attempted pulling line back to eliminate loop x 2.Picc was removed on (b)(6) and new picc order placed." no other information was provided.Additional information received on 2/28/2023: catheter had been secured with securacath.Additional information received on 5/25/2023: catheter inserted 13cm above the antecubital fossa and 3cm was left external to the patient.
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.

• Brand Name: POWERPICC 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 olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16461011
• Report Number: 3006260740-2023-00592
• Device Sequence Number: 12405371
• Product Code: LJS
• UDI-Device Identifier: 00801741152566
• UDI-Public: (01)00801741152566
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• 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: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: CK000819
• Device Lot Number: REGR1787
• 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: 04/01/2022
• 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: 50 YR
• Patient Sex: Unknown
• Patient Weight: 51 KG