MAUDE Adverse Event Report: POWERLOC SAFETY INFUSION SET 19G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking infusion set was unconfirmed because the problem could not be reproduced.The product returned for evaluation was one 19ga x 0.75¿ powerloc safety infusion set.Usage residues were observed throughout the sample and the safety mechanism was engaged.Precipitate was observed within the luer orifice.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion and aspiration with no observed leaks.No leaks were observed during sustained (>15 seconds) hydraulic pressurization.Microscopic inspection of the sample was unremarkable.No deficiencies were discovered during evaluation of the returned sample.Consequently this complaint is unconfirmed at this time.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 "when the nurse was priming the needle ns solution came out of the needle housing verses the tip of the needle.The needle was not used in accessing the pt mediport and sent down to supply.Needle size 0.75 inch.".

• Brand Name: POWERLOC SAFETY INFUSION SET 19G X 0.75IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12542696
• Report Number: 3006260740-2021-04030
• Device Sequence Number: 11606363
• Product Code: FPA
• UDI-Device Identifier: 00801741047732
• UDI-Public: (01)00801741047732
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2021

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: 0651934
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 09/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other