MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER BASIC TRAY (5F) (TRIPLE-LUMEN) (55CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cellulitis (1768); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a picc causing or contributing to a reaction in a patient is inconclusive and could not be verified from the returned photographs.Two photographs of a single lumen powerpicc catheter was returned for evaluation.An initial visual observation of the photographs showed a single lumen powerpicc inserted into a patient¿s arm.The catheter was observed to be secured by a statlock device and dressed at an angle, nearly perpendicular to the patient¿s arm.The patient¿s arm appeared to be swollen, and the patient¿s skin below the insertion site of the catheter appeared to be damaged.The catheter hub was observed to be secured to the patient¿s arm and appeared to be attached to some sort of triple extension leg connector.While the cause of the reported patient reaction could not be determined from the returned photographs, possible causes of irritation, infection, or other such reactions include, but are not limited to contamination of the insertion site, exposure to harsh chemicals, and patient condition/sensitivities.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.As a note, vad products are sterilized using ethylene oxide (eo).The sterilization cycle has been validated by the very conservative over-kill (half cycle) method in accordance with ansi/aami/iso 11135:2014 annex b sterilization of health care products¿ethylene oxide¿requirements for development, validation and routine control of a sterilization process for medical devices (fda consensus standard as of 04/04/2016).Validation and revalidation have demonstrated that the sterilization cycle exceeds the minimum sterility assurance level of 10^-6.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that that picc was causing cellulite in the pax.No other information was provided.

• Brand Name: POWERPICC CATHETER BASIC TRAY (5F) (TRIPLE-LUMEN) (55CM)
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kayla olsen ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225010
• MDR Report Key: 10145356
• MDR Text Key: 195931169
• Report Number: 3006260740-2020-02074
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741139963
• UDI-Public: (01)00801741139963
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K053501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 8375118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Event Location: Hospital
• Date Manufacturer Received: 05/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention