MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	0141975
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of ascps0200 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that there was a leak where the tubing connected into the hard plastic at the top of the huber needle.No patient injury reported.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a leak is confirmed and appears to be supplier related.One 19 ga x 0.75 in powerloc max was returned for investigation.A needleless injection connector was also returned.No apparent damage was observed on the outer surface of the device.Tactile evaluation revealed nothing remarkable.The sample was infused with water using a 12 ml syringe and a leak was observed at the top proximal end of the clear needle housing.The extension tubing detached from the needle housing during infusion.Microscopic observation of the tubing with uv lighting revealed small amounts of adhesive and was not uniform around the tubing.No ring or flange of adhesive was observed on the tubing or within the needle housing.As a leak was observed and the extension tubing detached during functional testing, it is likely that the issues were caused by inadequate adhesive bonding; therefore, the complaint is confirmed and appears to be supplier related.The supplier has been notified of this event.A lot history review (lhr) of ascps0200 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that there was a leak where the tubing connected into the hard plastic at the top of the huber needle.No patient injury reported.

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G X 0.75IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7500817
• Report Number: 3006260740-2018-00944
• Device Sequence Number: 126099
• Product Code: FPA
• UDI-Device Identifier: 00801741047435
• UDI-Public: (01)00801741047435
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2018

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 Catalogue Number: 0141975
• Device Lot Number: ASCPS0200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 05/09/2018
• Supplement Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1