MAUDE Adverse Event Report: UNKNOWN PICC; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Device Problem Obstruction of Flow (2423)

Patient Problems Liver Damage/Dysfunction (1954); Rash (2033); Renal Failure (2041); Urticaria (2278)

Event Date 10/08/2022

Event Type  Injury  

Event Description

Narrative: 65-year-old male with pmh of pvd, htn, dm2, hld, hx of rle tma amputation who was discharged on (b)(6) 2022 after treatment for poor healing ulcer, osteomyelitis, patient was sent home with picc line on iv cefepime and po metronidazole.Patient returned to emergency room on (b)(6) 2022 because picc line was clogged and reports shortly after discharge on (b)(6) 2022 he developed rash in his b/1 legs, up to his thighs and few spots on his arm with mild itching, sensitivity, and no sloughing of the skin.Per patient, the only new medications started were in the hospital was cefepime, metronidazole, and pantoprazole 20 mg.During readmission in the ed, picc line was flushed with alteplase and cefepime was administered.Patient was admitted for rash.Pantoprazole, cefepime, and metronidazole were also discontinued at this time ((b)(6) 2022).Rash treated with diphenhydramine, prednisone, and methylprednisolone.On (b)(6) 2022, patient's serum creatinine began to rise, peaking at 6.38 on (b)(6) 2022.He underwent a kidney biopsy, scr improved, rash has faded.Patient was discharged on po levofloxacin and iv daptomycin for om.Symptom : symptom : i.Rash, 2.Urticariapruritus, 3.Elevatedbunscr, 4.Acuterenalfailure.

• Brand Name: PICC
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 15980133
• MDR Text Key: 305559132
• Report Number: MW5113783
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: CEFEPIME (CEFEPIME HCL 1GM/VIL INJ); METRONIDAZOLE; PANTOPRAZOLE (PANTOPRAZOLE NA 20MG TAB,EC)
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 113 KG