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

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 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.

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 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
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8612124
• MDR Text Key: 145230597
• Report Number: 3006260740-2019-01379
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741047411
• UDI-Public: (01)00801741047411
• Combination Product (y/n): N
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1