MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC PORT ACCESS KIT 20G X 1 IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/19/2020
Type of Reportable Event	Malfunction
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 a damaged safety mechanism is confirmed but the exact cause could not be determined.One 20 ga x 1 in powerloc infusion set was returned for investigation.The port access kit and powerloc infusion set packaging were also returned opened.The product numbers showed lot: redw2519 and lot: asdus0054 respectively.The safety mechanism on the infusion set was not activated.The translucent, winged base was not present on the safety mechanism and was not returned.The orange safety component was rolled outward but still attached to the pin holes on the yellow housing.Based on the condition of the returned sample, possible contributing factors include excessive manipulation during storage or handling.The condition of the device prior to kit opening could not be determined; therefore, the exact cause is unknown.A lot history review (lhr) of redw2519 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the safety needle broke.Additional information received via email: "there was no patient injury.The defective product was discovered on (b)(6) 2020 when a picc team nurse opened the package to access the safety needle, and found the orange safety mechanism was broken before even trying to use it.Thankfully, the nurse didn¿t wound herself or the patient.".

• Brand Name: POWERLOC PORT ACCESS KIT 20G X 1 IN 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: 9727168
• Report Number: 3006260740-2020-00542
• Device Sequence Number: 19368005
• Product Code: LJT
• UDI-Device Identifier: 00801741044540
• UDI-Public: (01)00801741044540
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2020

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 Expiration Date: 02/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 2672010
• Device Lot Number: REDW2519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1