MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERHICKMAN 9.5F DUAL-LUMEN POLYURETHANE CATHETER WITH SURECUFF INGROWTH CUFF; LONG TERM INTRAVASCULAR CATHETER

Catalog Number	0805910
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/19/2016
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.A lot history review (lhr) of rear0025 showed no other similar product complaint(s) from this lot number.The manufacturer has received the sample and will evaluate.Results are expected soon.
Event or Problem Description
On 5/25/16 - it was reported by complainant that the hickman packaging has a slit and a mark on the outside of the package.They also reported that there was "sweat" in the packaging.

• Brand Name: POWERHICKMAN 9.5F DUAL-LUMEN POLYURETHANE CATHETER WITH SURECUFF INGROWTH CUFF
• Common Device Name: LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5730205
• Report Number: 3006260740-2016-00277
• Device Sequence Number: 16145838
• Product Code: LJS
• UDI-Device Identifier: 00801741036682
• UDI-Public: (01)00801741036682(17)180228(10)REAR0025
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K061179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2016

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: 0805910
• Device Lot Number: REAR0025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2016
• Initial Report FDA Received Date: 06/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1