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
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of ascys0071 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that when opening the kit, it was noticed that the cover of needle was not contained in it.There was no reported patient involvement.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a missing component is inconclusive due to the state of the returned sample.One 20 g x 0.75 in.Powerloc winged infusion set with y-site in an opened package was returned for evaluation.An initial visual observation showed obvious evidence of use.The needle shaft was observed to be slightly bent at its base.The needle guard was not returned with the sample.The opened state of the packaging made it difficult to assess when and where the component went missing.Possible causes include improper kit packaging and misplacement of kit components after opening.A lot history review (lhr) of ascys0071 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that when opening the kit, 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 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: 8879676
• Report Number: 3006260740-2019-02361
• Device Sequence Number: 11336498
• 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): 09/11/2019

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
• Device Lot Number: ASCYS0071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1