MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH NURSING BASIC TRAY AND MICROEZ MICROINTRODUCER KIT; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	3295118
Health Effect - Clinical Codes	Dyspnea (1816); Discomfort (2330); Reaction (2414)
Date of Event	04/25/2016
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, as the device remains in the patient.A lot history review (lhr) of rezl1760 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that during picc insertion, a patient allegedly experienced facial flushing lasting approximately 30 seconds, difficulty taking a full breath, stomach warmth, and abdominal discomfort.Entire reaction resolved in approximately 5 minutes.Oxygen was applied during reaction and vital signs were stable throughout reaction.Patient stated that she "felt completely normal" after approximately 5 minutes.Picc was left in situ in patient.

• Brand Name: POWERPICC SOLO CATHETER WITH NURSING BASIC TRAY AND MICROEZ MICROINTRODUCER KIT
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5693190
• Report Number: 3006260740-2016-00244
• Device Sequence Number: 45049
• Product Code: LJS
• UDI-Device Identifier: 00801741028090
• UDI-Public: (01)00801741028090(17)170628(10)REZL1760
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/12/2016

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 Expiration Date: 06/28/2017
• Device Catalogue Number: 3295118
• Device Lot Number: REZL1760
• 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: 06/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1