MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD POWERPICC SOLO; 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 Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 04/04/2023

Event Type  Injury  

Manufacturer Narrative

H11: section a through f - the information provided by bd represents all of the known information at this time.This complaint was received as part of a clinical survey.Contact information and specific patient details were not disclosed as part of the survey.As such, additional information and the subject sample cannot be obtained.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 device has not been returned to the manufacturer for evaluation.H3 other text : device not returned for evaluation.

Event Description

It was reported "the following was obtained during clinical assessment: redness or swelling was identified at or around the central line insertion site.The event involved a sl powerpicc solo in the upper arm.".

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 Description

It was reported "the following was obtained during clinical assessment: redness or swelling was identified at or around the central line insertion site.The event involved a sl powerpicc solo in the upper arm.".

• Brand Name: BARD POWERPICC SOLO
• Type of Device: 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16777768
• MDR Text Key: 313664482
• Report Number: 3006260740-2023-01461
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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