MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 5 FR DL POWERPICC SOLO CATHETER, 70CM NITINOL; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	3295355
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/06/2017
Type of Reportable Event	Malfunction
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 manufacturer has received the sample and will be evaluated.Results are expected soon.A lot history review (lhr) of reav2510 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported on (b)(6) 2017 that the picc was leaking.The healthcare professional was not able to visualise the leak when flushing but was very obvious on inspection of the picc while insitu that the antibiotic was leaking and no leak was reported from the bung.There was no reported patient 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 initial complaint appeared to be a reportable occurrence.The evaluation of the returned sample revealed no evidence to support the allegation of a leak in the catheter.The reported event indicates the clinician could see leaking while the catheter was insitu, suggesting the alleged leak was external to the patient.No injury to the patient, user, or other person was reported or suggested in the alleged event.As no evidence of a leak existed on the returned sample, the allegation of a device malfunction is unconfirmed.This does not require and mdr submission per cfr 21 part 803.
Event or Problem Description
It was reported on (b)(6) 2017 that the picc was leaking.The healthcare professional was not able to visualise the leak when flushing but was very obvious on inspection of the picc while insitu that the antibiotic was leaking and no leak was reported from the bung.There was no reported patient injury.

• Brand Name: 5 FR DL POWERPICC SOLO CATHETER, 70CM NITINOL
• 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: 6525695
• Report Number: 3006260740-2017-00511
• Device Sequence Number: 1458013
• Product Code: LJS
• UDI-Device Identifier: 00801741028144
• UDI-Public: (01)00801741028144(17)180228(10)REAV2510
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 3295355
• Device Lot Number: REAV2510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/25/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 05/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1