MAUDE Adverse Event Report: POWERLOC SAFETY INFUSION SET 19G X 1 IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asexf030 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via ms&s "nurse asking about drawing blood using powerloc needle with ports as she is hearing reports of numerous hemolyzed blood samples recently.Nurse has some concern that technicians drawing blood may not have proper training." ms&s response: "reviewed blood sampling procedure section of powerport nursing guide - powerport implantable port, powerloc safety infusion set and emailed to caller per request.Also discussed checking port for patency prior to use.Provided customer service number (b)(6) for caller to obtain facility sales representative and their clinical specialists contact information for staff education and training options with bard/bd products.Sent case to product complaints/fa." additional info.Received 07/29/2021 "the product itself is not an issue.The question was proper technique being used to get lab draws.The hospital has new equipment that is ¿more sensitive¿ to the lab samples and are resulting as hemolyzed specific to lab draws from ports.The lab is asking that we use the transfer device hooked directly to the port hub instead of drawing via 10 cc syringe and transferring into the lab tube to prevent hemolysis.My inquiry was not due to faulty product but manufacturer recommendations for nursing.".

• Brand Name: POWERLOC SAFETY INFUSION SET 19G X 1 IN WITH Y-SITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12351437
• Report Number: 3006260740-2021-03445
• Device Sequence Number: 19763640
• Product Code: FPA
• UDI-Device Identifier: 00801741047893
• UDI-Public: (01)00801741047893
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 08/02/2021

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: 0671910
• Device Lot Number: ASEXF030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other