MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA INJECTOR N35-O; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515052

Device Problem Failure to Infuse (2340)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2022

Event Type  malfunction  

Event Description

It was reported that while using a bd phaseal¿ optima injector n35-o, there were flow issues with the device.The following information was provided by the initial reporter: the chemo would not flow.

Manufacturer Narrative

Initial reporter facility name: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval yes.D9: returned to manufacturer on: 03-may-2022.H6: investigation summary one sample unit was returned for evaluation by our quality engineer team.Upon visual inspection of the sample, no defects were observed.Testing was performed and fluid was able to flow between the injector and connector without issue.The injector was disassembled for further evaluation, no damage or defects within any of the components was observed and no indication of an occlusion or other obstruction was identified.A device history review was performed for lot 2111308, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Product undergoes visual and functional inspections prior to release, including verification the product is not damaged, flow rate, and all critical dimensions meet specifications.Upon reviewing the results for lot 2111308, no issues were identified during testing and the product met the required criteria for release.Five retained samples of the same lot were used for additional evaluation.The samples were functionally tested and, in all cases, flow was observed and the product functioned as intended.Based on our investigation and sample evaluation, we cannot identify a root cause at this time.

Event Description

It was reported that while using a bd phaseal¿ optima injector n35-o, there were flow issues with the device.The following information was provided by the initial reporter: the chemo would not flow.

• Brand Name: BD PHASEAL¿ OPTIMA INJECTOR N35-O
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14219964
• MDR Text Key: 290191130
• Report Number: 3003152976-2022-00171
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181221
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 515052
• Device Lot Number: 2111308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1