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
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was inconclusive since the product was not returned for evaluation.Based on the description of the reported event, some possible contributing factors include ; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).Consequently, this complaint is inconclusive at this time.The complaint of a leak is confirmed to be supplier related.One 19 ga x 0.75 in powerloc max safety infusion set was returned for investigation.The white dust cap was attached to the y-site luer adapter.A second luer cap was returned unattached.A yellowish-brown fluid was observed within the extension tubing.The y-site luer was wrapped in gauze dressing.The infusion set was flushed and pressurized and no leaks were observed.An iso compliant taper gauge was used and found the luer hubs to be within specification.An attempt to attach one of the white luer caps to the hub was unsuccessful.Microscopic observation of the luer cap revealed adhesive to be present.A bridge of adhesive was formed between the center stem and inner wall which likely caused the cap to not fully tighten.Since the adhesive appeared to have been deposited during the manufacturing process, the complaint is confirmed.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 needle of powerloc was accessed to the port body of power port and contrast medium was infused, back flow of the contrast medium to the luer connector on the unused side was found.It was further reported that although the cap of the unused luer connector had been closed, the contrast medium leaked from the gap of the cap.There was no reported patient injury.
Event or Problem Description
It was reported that when the needle of powerloc was accessed to the port body of powerport and contrast medium was infused, back flow of the contrast medium to the luer connector on the unused side was found.It was further reported that although the cap of the unused luer connector had been closed, the contrast medium leaked from the gap of the cap.There was no reported patient injury.
Additional Manufacturer Narrative
The complaint of a leak is confirmed to be supplier related.One 19 ga x 0.75 in powerloc max safety infusion set was returned for investigation.The white dust cap was attached to the y-site luer adapter.A second luer cap was returned unattached.A yellowish-brown fluid was observed within the extension tubing.The y-site luer was wrapped in gauze dressing.The infusion set was flushed and pressurized and no leaks were observed.An iso compliant taper gauge was used and found the luer hubs to be within specification.An attempt to attach one of the white luer caps to the hub was unsuccessful.Microscopic observation of the luer cap revealed adhesive to be present.A bridge of adhesive was formed between the center stem and inner wall which likely caused the cap to not fully tighten.Since the adhesive appeared to have been deposited during the manufacturing process, the complaint is confirmed.The supplier has been notified of this event.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 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: 8777264
• Report Number: 3006260740-2019-01899
• Device Sequence Number: 2666734
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1