MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515052

Device Problem Inflation Problem (1310)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 1805701, medical device expiration date: 2019-04-30, device manufacture date: 2018-05-22. Medical device lot #: 1806708, medical device expiration date: 2019-11-30, device manufacture date: 2018-06-26. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that during use of the bd phaseal optima the p20-o would not re inflate. The following information was provided by the initial reporter: the expected outcome should have the p20-o re inflate once it has been previously deflated. The pir is the protector p20-o is not re inflating when an injectors n35-o is attached. Once the initial 50 ml of air is deflated with 50 ml drug withdraw the expansion chamber is not re-inflating when the n35-o is attached. The expected outcome is to remove the reminder of the drug, demonstrating the expansion chamber needs to re-inflate. Without the expansion chamber it creates great effort and muscle strain as verbalized by the pharmacy technician to withdraw drug. The incident appears to happen consistently with 5fu infuser preparations and with larger dose taxol drugs.

• Brand Name: BD PHASEAL¿ OPTIMA
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8480664
• MDR Text Key: 148635555
• Report Number: 3003152976-2019-00246
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K181221
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515052
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/12/2019
• 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 Treatment Data

Date Received: 04/03/2019 Patient Sequence Number: 1