MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G X 1.0 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of ascys0017 showed no other similar product complaint(s) from this lot number.Device not yet received.
Event or Problem Description
It was reported via ms&s that there was a hair found inside powerloc max kit.Kit was opened, but not used on patient and reported no harm.
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 hair found within the infusion set packaging was confirmed and the cause was supplier-related.The product returned for evaluation was one 19ga x 1¿ powerloc max safety infusion set.The sample was received in its original sealed packaging.A fiber was observed within the sealed package.Microscopic inspection of the sample confirmed the presence of a hair-like fiber within the sealed packaging.Hair-like material was observed within the returned infusion set packaging.The sealed state of the packaging indicated that the material was deposited during device packaging at the manufacturing site.The device is a supplied component and the supplier has been notified of this event.
Event or Problem Description
It was reported via ms&s that there was a hair found inside powerloc max kit.Kit was opened, but not used on patient and reported no harm.

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G X 1.0 IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8612124
• Report Number: 3006260740-2019-01379
• Device Sequence Number: 19332427
• Product Code: FPA
• UDI-Device Identifier: 00801741047411
• UDI-Public: (01)00801741047411
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2019

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: 0141910
• Device Lot Number: ASCYS0017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1