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	Defective Component (2292)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/08/2019
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 the nurse stopped using the powerloc to the patient because the needle was loose.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 ¿loose needle¿ is inconclusive due to poor sample condition.One 20 ga x 0.75 in powerloc swis w/ysite was returned for investigation.The safety mechanism was not activated.No apparent evidence of use was observed.The needle was observed to be stable with the yellow barbs locked in with the clear housing.Excessive manipulation of the yellow connecting hinge and clear housing resulted in the safety mechanism partially dislodging.The safety mechanism was able to be assembled back into place.The safety mechanism was able to be fully activated.No issues were observed.The condition of the infusion set prior to package opening and how it was handled during use is unknown; therefore, the complaint is inconclusive.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 the nurse stopped using the powerloc to the patient because the needle was loose.There was no reported patient involvement.

• 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: 9305764
• Report Number: 3006260740-2019-03512
• Device Sequence Number: 16651649
• 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): 12/11/2019

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: 11/07/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/21/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1