MAUDE Adverse Event Report: BECTON DICKINSON AND CO. VIAL ADAPTER ++ Q-STYLE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 385108

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

Patient Problem Erythema (1840)

Event Type  Injury  

Event Description

Patient reports that when she spiked her vials sometimes the stopper will get a slit and remodulin will leak out (dates unknown) sent patient alternate adapter.Patient also reports currently experiencing red marks on the bridge of her nose and along the creases by her mouth.Indication: pulmonary arterial hypertension (pah).No additional adverse events or side effects were mentioned by patient due to product issue.Lot and expiration date are unknown.Unknown if patient still has product on hand.Advised to inform md.No further information was provided.Reported to (b)(6) by: patient/caregiver.

• Brand Name: VIAL ADAPTER ++ Q-STYLE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON AND CO.
• MDR Report Key: 9437717
• MDR Text Key: 170423993
• Report Number: MW5091522
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 385108
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1