MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that when the powerloc was primed before use to the patient, saline solution leaked from the vicinity of the connection between the tube and the needle housing.There was no reported patient involvement.
Event or Problem Description
It was reported that when the powerloc was primed before use to the patient, saline solution leaked from the vicinity of the connection between the tube and the needle housing.There was no reported patient involvement.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a leaking needle is unconfirmed since the problem could not be reproduced.One 20 ga x 0.75 in powerloc infusion set was returned for investigation.The white luer caps were present on the y site and proximal connectors.The safety mechanism was not activated.White crystalline material was present within the extension tubing which is likely residual material from saline solution.Microscopic observation of the extension tubing near the needle housing revealed no apparent damage or gaps between the adhesive bond.The sample was flushed with water using a 10 ml syringe and was found to be patent to infusion.The needle was occluded using a non-complainant port septum in order to pressurize the device.No leaks were observed.The connection point between the extension tubing and needle housing was manipulated, and no fluid was observed to leak.Since the device was not observed to leak during infusion, pressurization, and manipulation of the extension tubing, the complaint could not be confirmed.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

• Brand Name: POWERLOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9234335
• Report Number: 3006260740-2019-03323
• Device Sequence Number: 18918366
• Product Code: FPA
• UDI-Device Identifier: 00801741151477
• UDI-Public: (01)00801741151477
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2019

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 Model Number: N/A
• Device Catalogue Number: 0672034J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1