MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD POWERLOC; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported via ms&s "can you tell me why my wife is having her hemoglobin come back low when drawn through the powerloc and not through her iv.Could you offer advice on techniques you have used to fix this issue?" ms&s response "informed caller that the nurse would need to follow facility protocol for blood draw through a port.Discussing with ordering doctor and lab would ensure the correct techniques are used." on 09/13/2021 additional info rcvd "no complaints, only that i was troubleshooting why the hemoglobin counts have been reported as 30% lower when drawing from her port vs directly from the vein.We are theorizing it¿s operator error from the nurse doing the draw.".

• Brand Name: BARD POWERLOC
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12558543
• MDR Text Key: 274275891
• Report Number: 3006260740-2021-04094
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other