C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2 CATHETER BASIC TRAY (4F) (SINGLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Foreign Body Reaction (1868)
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Event Date 10/12/2022 |
Event Type
Injury
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Event Description
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It was reported on (b)(6) 2022, a picc was implanted for the patient.On october 12, an infection was found near the puncture site of the patient.Immediately discontinue use and report adverse events.2022-10-27 additional information received: is there any other port of entry that may cause infection? any recent surgery? the patient was allergic and had adhesive residue in the catheter fixation device.No recent surgery.What is the primary diagnosis of patient? atopic dermatitis and adhesives in catheter fixtures cause dermatitis and infection.Were blood cultures and lab work taken? no.Was the tip of the catheter cultured? what were the results? no.Was the line removed? was the line replaced? no.
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Manufacturer Narrative
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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 device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refw0196 showed no other similar product complaint(s) from this lot number.
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