MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 4F SINGLE-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Codes	Itching Sensation (1943); Rash (2033); Urticaria (2278)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information provided by bard 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 bard.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of rebw2155 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (rebw2155) have been reported from the same facility.
Event or Problem Description
It was reported by the facility that the patient had a powerpicc placed and had "some sort of allergic reaction".The picc was removed and a groshong cvc was placed.It was reported that chloraprep was used before and after both insertions.This file addresses the reaction to the initial picc placement.On (b)(6) 2018 - additional information reported by the facility.Picc was placed on (b)(6) 2017.The first week in (b)(6) she became itchy and had hives on her chest at the insertion site and continued down her arm where the picc ended.The picc fell out due to excessive scratching while the patient slept.Patient was given iv antibiotics for two weeks for the rash.A new picc was placed on (b)(6) 2017.Two weeks after placement the patient developed a rash on the other side with the second picc.

• Brand Name: POWERPICC 4F SINGLE-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7301600
• Report Number: 3006260740-2018-00296
• Device Sequence Number: 1801532
• Product Code: LJS
• UDI-Device Identifier: 00801741027635
• UDI-Public: (01)00801741027635
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3174355
• Device Lot Number: REBW2155
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1