MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC SAFETY INFUSION SET 19G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/19/2019
Type of Reportable Event	Malfunction
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 missing needle cover is inconclusive due to poor sample condition.One 19 x 0.75 in powerloc infusion set was returned for investigation with opened packaging.The lot number on the label showed ascps0013.The white dust caps are present on both luer hubs.The safety mechanism was not activated over the needle bevel.No evidence of use was observed throughout the device.The needle cover was not returned.No punctures or damage to the packaging was observed.The presence of the needle cover prior to package opening could not be determined from the sample provided; therefore, the complaint is inconclusive due to poor sample condition.A lot history review (lhr) of ascps0013 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that immediately after opening the package, it was noticed that the cover of needle was not contained in it.There was no reported patient involvement.

• Brand Name: POWERLOC SAFETY INFUSION SET 19G 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: 9088498
• Report Number: 3006260740-2019-02754
• Device Sequence Number: 11467925
• Product Code: FPA
• UDI-Device Identifier: 00801741151453
• UDI-Public: (01)00801741151453
• 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
• Report Date (Section B): 09/19/2019

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: 0671934J
• Device Lot Number: ASCPS0013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1