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

Catalog Number	515053
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd phaseal¿ optima injector (n35-o multi) was damaged and missing the polysoprene membrane.The following information was provided by the initial reporter, translated from (b)(6) to english: detected a non-conformity in phaseal optima injector -n35-o multipack.The device is missing the polysoprene membrane that protects the needle inside the injector body.Has not been used.No impact encountered, the operator noticed the lack of polysoprene membrane before proceeding to handle the antiblastic drug.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-05-08.H6: investigation summary: one sample and one photo was provided to our quality team for investigation.Through visual inspection, the membrane was observed to have separated from the injector.Further evaluation identified that the hole on the bottom of the membrane was clogged which likely prevented proper assembly between the membrane and injector cannula during assembly.A device history review was performed for lot 2010316, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Five retained samples of the same lot were used for additional evaluation.The product was visually inspected and no defects were identified, all injectors were properly assembled and no membranes were observed to be clogged.Product undergoes visual and functional inspections throughout the manufacturing process to ensure the quality and functionality of the device.No issues related to this issue were identified during the inspection process.While we cannot identify a direct issue, the clog within the membrane likely prevented proper assembly and lead to the membrane disconnecting from the injector as observed in the product evaluated.The membrane for this product is provided by a supplier whom we have notified of this incident.
Event or Problem Description
It was reported that the bd phaseal¿ optima injector (n35-o multi) was damaged and missing the polysoprene membrane.The following information was provided by the initial reporter, translated from italian to english: detected a non-conformity in phaseal optima injector -n35-o multipack.The device is missing the polysoprene membrane that protects the needle inside the injector body.Has not been used.No impact encountered, the operator noticed the lack of polysoprene membrane before proceeding to handle the antiblastic drug.

• Brand Name: BD PHASEAL OPTIMA INJECTOR (N35-O MULTI)
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 11548142
• Report Number: 3003152976-2021-00159
• Device Sequence Number: 3148001
• Product Code: ONB
• UDI-Device Identifier: 00382905150531
• UDI-Public: 00382905150531
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K181221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 515053
• Device Lot Number: 2010316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2021
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1