MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4 FR SL POWERPICC SOLO CATHETER, BASIC; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2017
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of reaw1818 showed no other similar product complaint(s) from this lot number.Device not returned, at this time.
Event or Problem Description
It was reported on (b)(6) 2017 that there was leaking at the site.The dressings were also reportedly damp causing the line to be exposed to possible migration/infection.There was no reported patient injury.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a leak from the catheter was unconfirmed since the problem could not be replicated.One 4 fr s/l powerpicc solo was provided for investigation.The catheter extended to the 50cm depth mark.A functional test of the catheter revealed nothing remarkable.It was reported that there was leaking at the site, but the exact cause of the reported event is unknown.No leaks were observed in any part of the catheter.No air would enter the catheter when the tubing was subject to a negative pressure.A microscopic examination of the catheter revealed no holes or damage.
Event or Problem Description
It was reported on (b)(6) 2017 that there was leaking at the site.The dressings were also reportedly damp causing the line to be exposed to possible migration/infection.There was no reported patient injury.

• Brand Name: 4 FR SL POWERPICC SOLO CATHETER, BASIC
• 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: 6659826
• Report Number: 3006260740-2017-00888
• Device Sequence Number: 72573
• Product Code: LJS
• UDI-Device Identifier: 00801741027741
• UDI-Public: (01)00801741027741(17)180331(10)REAW1818
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 08/04/2017

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: 03/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 3194118
• Device Lot Number: REAW1818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 06/22/2017
• Supplement Report FDA Received Date: 08/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1