MAUDE Adverse Event Report: WEST PHARMA. SERVICES IL WEST PHARMA. SERVICES IL VIAL2BAG DC 13MM

Model Number 6070111

Device Problems Excess Flow or Over-Infusion (1311); Infusion or Flow Problem (2964); Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 10/13/2018

Event Type  Injury  

Event Description

When using the vial2bag 13mm adapter with the 20u pitocin vials on 3 different occasions minutes after initiating the pitocin for their inductions, hyperstimulation of contractions occurred.On the 1st patient, the hyperstimulation caused fhr decel.That ultimately ended in a c-section.The 2nd event happened minutes after initiating the pitocin induction, the patient was noted to have hyperstimulation of contractions and the induction was stopped.3rd incident happened the same way.No fetal heart rate decels., but the induction had to be stopped because of hyperstimulation.These events occurred with 3 different nurses and 3 different patients.When this occurred with the second patient we started thinking it was due to pitocin not being mixed in the 1000cc bag adequately.When the 3rd nurse mixed the pitocin for the 3rd induction we made sure we used the vial2bag adapter as inserviced.When we had the same results after initiating the induction we called the pharmacist and voiced our concern.

• Brand Name: WEST PHARMA. SERVICES IL VIAL2BAG DC 13MM
• Type of Device: VIAL2BAG DC 13MM
• Manufacturer (Section D): WEST PHARMA. SERVICES IL; 4 hasheizaf street; ra'anana hamerkaz, 43664 11; IS 4366411
• MDR Report Key: 8192623
• MDR Text Key: 131304669
• Report Number: 3000223297-2018-00003
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 07290108240061
• UDI-Public: (01)07290108240061(17)210701(10)A124(90)36098125(91)6070111
• Combination Product (y/n): N
• PMA/PMN Number: K170095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Model Number: 6070111
• Device Lot Number: A124
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES81877
• Patient Sequence Number: 1
• Treatment: PITOCIN
• Patient Outcome(s): Required Intervention