MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 20G X 1IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking infusion set was confirmed and the cause appeared to be supplier-related.The product returned for evaluation was one 20ga x 0.75¿ powerloc safety infusion set.Light usage residues were observed throughout the sample.The adhesive within the proximal adhesive application site appeared to be irregular.Microscopic inspection of the sample using an ultraviolet light revealed a void in the adhesive within the proximal application site.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion; however, a leak was observed emanating from the proximal adhesive application site, through the void in the adhesive.The fluid path resulting in the observed leakage appeared to have been caused by incomplete adhesive coverage at the tubing/needle/housing joint.A void(s) in the adhesive appeared to have occurred during device assembly.The device is a supplied component and the supplier has been notified of this event.A lot history review (lhr) of asdtf112 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "there was a small crack in the plastic piece that covers the port needle and when they went to flush, the saline sprayed out of the crack."on (b)(6) 2020- the returned device leaked from the needle.

• Brand Name: POWERLOC SAFETY INFUSION SET 20G X 1IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11202568
• Report Number: 3006260740-2020-21392
• Device Sequence Number: 14414506
• Product Code: FPA
• UDI-Device Identifier: 00801741047749
• UDI-Public: (01)00801741047749
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/31/2020

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 Model Number: N/A
• Device Catalogue Number: 0652010
• Device Lot Number: ASDTF112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 01/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other