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 08/14/2017

Event Type  Injury  

Event Description

(b)(6), the dop (at (b)(6)) had 4 occurrence reports from labor and deliver of severe and rapid contractions beginning about 10 minutes after oxytocin 20 unit infusion (using v2bdc inline) was started.They reported concerns with increased heart rate of the baby and said they almost had to bring these patients in for emergency c section ((b)(6) thought this morning they may have had to do an emergency c section on one patient).The l/d nursing director noticed that the vial furthest from the bag was not emptying completely and was concerned that the patient was getting an initial bolus of oxytocin when using vial2bag dc inline.The dop assembled it himself and noted that the vial2bagdc 13mm adapter did not fit tightly to the oxytocin 10 unit vial and when attempting to mix the drug into the bag, only the vial closest to the bag was emptying completely but the second vial was maintaining concentrated drug that would not transfer out of the vial, even with adequate air in the bag.The dop described it as a "pressure lock" and said he couldn't transfer anything into or out of the second vial at that point.They stopped using v2bdc with oxytocin after the l/d nursing director came to the dop office this morning and shared her concerns and gave them the details of the adverse event reports.Terry said this was app brand oxytocin.(b)(6) also mentioned that they are having great success with vial2bagdc otherwise but could use additional inservicing in the preop area where he has had repeated leaking reports with cefazolin.

• 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: 8198202
• MDR Text Key: 131488638
• Report Number: 3000223297-2018-00014
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 07290108240061
• UDI-Public: (01)07290108240061(17)200604(10)9175(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: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2020
• Device Model Number: 6070111
• Device Lot Number: 9175
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES81877
• Patient Sequence Number: 1
• Treatment: OXYTOCIN
• Patient Outcome(s): Required Intervention