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 Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2019
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 during the contrast ct examination after the needle of power lock was accessed to the port body of power port, the physician found that blood vessel was not be displayed.Therefore, the line was checked and it was turned out that the cap was detached from the connector of unconnected side and the contrast medium was leaked from the connector.There was no reported patient injury.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s) and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of fluid leak is inconclusive due to poor sample condition.One 20 ga x 0.75 in powerloc infusion set was returned for investigation.The proximal luer hub is attached to an extension set with a 3-way valve.The infusion set safety mechanism is fully advanced and activated over the needle.Use residue is present within the extension tubing.The white cap was attached to the y-site luer.An attempt to remove the extension set from the proximal luer required excessive force.The sample was flushed and pressurized through the proximal luer with water using a 12 ml syringe and no leaks were observed.The y-site luer cap was removed and residual material was observed to be present around the luer connector and within the white cap.An iso compliant taper gauge was used and found the proximal connector to be within specification.The y-site luer was found to be slightly larger than specification; however, since evident of use and over-tightening was present, the condition of the device prior to use is unknown.The white cap was also able to be tightened securely and did not leak during pressurization.Since the issues could not be replicated during functional testing, the complaint is inconclusive.Possible contributing factors include loose connector prior to use.The product ifu warns."warnings:¿ fully tighten all connections, y-site end caps, or needleless connectors before use.Failure to attach an end cap or appropriate needleless device after removing a male luer locking end cap or needleless connector can result in an embolism or bleeding.".
Event or Problem Description
It was reported that during the contrast ct examination after the needle of power lock was accessed to the port body of powerport, the physician found that blood vessel was not be displayed.Therefore, the line was checked and it was turned out that the cap was detached from the connector of unconnected side and the contrast medium was leaked from the connector.There was no reported patient injury.

• 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: 8818893
• Report Number: 3006260740-2019-02133
• Device Sequence Number: 16900827
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2019

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: 07/15/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 08/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR