MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC PORT ACCESS KIT 19G X 1 IN 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	03/29/2019
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) of recz2068 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (recz2068) have been reported from the same facility.
Event or Problem Description
It was reported that a plastic piece from a port needle broke off while patients port was being deaccessed.This occurred twice.This report addresses the second device.
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 broken safety mechanism is confirmed; however, the exact cause is unknown.One 19 g x 1.0 in.Powerloc winged infusion set with a y-site was returned for evaluation.An initial visual observation showed some use residue on the returned sample.One of the tabs of the clear base of the safety mechanism was observed to be broken at its base but still attached at one corner.A microscopic observation revealed the facture surface was rough, uneven, and angled.Cracking was observed extending from the corner of the break that was still attached to the rest of the base.Some plastic deformation was observed on the edges of the fracture.The angle of the fracture surface as well as the observed plastic deformation suggest the tab of the base may have fractured during de-accessing the port; however, the exact cause of this fracture is unknown.Possible contributing factors of this failure include excessive force during de-accessing, de-accessing technique, and damage during storage or handling.A lot history review (lhr) of recz2068 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (recz2068) have been reported from the same facility.
Event or Problem Description
It was reported that a plastic piece from a port needle broke off while patients port was being deaccessed.This occurred twice.This report addresses the second device.

• Brand Name: POWERLOC PORT ACCESS KIT 19G 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: 8551969
• Report Number: 3006260740-2019-01180
• Device Sequence Number: 2049331
• Product Code: LJT
• UDI-Device Identifier: 00801741044519
• UDI-Public: (01)00801741044519
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2019

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: 2671910
• Device Lot Number: RECZ2068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1