MAUDE Adverse Event Report: POWERFLOW IV ACCESSSYSTEM 14GA; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	AIV14
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 03/2022).Device not returned.
Event or Problem Description
It was reported that prior to port placement, the product packaging of port allegedly had a labelling issue.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.However, the device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for these reports.Investigation summary: the sample was not returned for evaluation.One electronic photos were provided for review.Upon reviewing the label on the white carton of the device in the jde, the quantity of the device mentioned in the label was found to be 5 (five), which is matching with the quantity in the provided label photo.Therefore based on the photo review the investigation is unconfirmed for an issue with the label on the white carton.He definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.` drawing reviewed: the drawing indicates: five kits are packaged in the white carton and 2 white cartons with 5 kits each are packaged in a brown shipping box, for a total of 10 kits in the brown shipping box.` h10: d4 (expiry date: 03/2022), g3, h6(method) h11: h6(result, conclusion) h11: section a through f ¿ the information provide by bd represents all 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 bd.H3 other text : device not returned.
Event or Problem Description
It was reported that prior to port placement, the product packaging of port allegedly had a labelling issue.There was no patient contact.

• Brand Name: POWERFLOW IV ACCESSSYSTEM 14GA
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• MDR Report Key: 11573939
• Report Number: 3006260740-2021-00971
• Device Sequence Number: 3544457
• Product Code: PTD
• UDI-Device Identifier: 00801741136634
• UDI-Public: (01)00801741136634
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K163001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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: AIV14
• Device Catalogue Number: AIV14
• Device Lot Number: REEX2977
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 08/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2020
• 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