MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL OPTIMA PROTECTOR (P20-O); INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515064

Device Problem Deflation Problem (1149)

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

Event Date 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a bd phaseal optima protector (p20-o) expansion chamber did not deflate.A plug was noticed in the expansion chamber.

Event Description

It was reported that a bd phaseal optima protector (p20-o) expansion chamber did not deflate.A plug was noticed in the expansion chamber.

Manufacturer Narrative

The information was re-evaluated and the complaint does not meet our mdr reporting criteria.When the expansion chamber does not deflate, this may lead to customer dissatisfaction or a delay in preparation, but it is unlikely to lead to any degree of harm/serious injury.

Manufacturer Narrative

H.6.Investigation summary: one picture was received showing some drops through the hydrophobic filter.No samples are available for investigation.Thirty-one (31) retained samples were taken for investigation.Visual inspection reveals no defects.Twenty (25) samples were inflated through the spike using a syringe with 50 ml of air.All of the samples expanded the chamber properly and no defects were found on the film.Functional test was performed on six (6) samples.The injector was connected to a syringe and attached to the protector + vial, following instructions explained in the ifu.In all cases expansion chamber worked properly (inflated and deflated properly).No leak was found through the hydrophobic filter.Inspections and tests: according to ph-322, visual inspection of protector takes place during manufacturing process.(the correct assembly of the components and the absence of foreign matter are verified).According to ph-322 leak test and burst test are performed on the first lot of each month using a z-axis equipment.The volume of the expansion chamber is checked on the first lot of each month according to ph-322/pc-225 as well.The machine has a leak test and flow test, both tests will detect if the sample has the channels 100% blocked in such a way that he chambers can´t be inflated.Flow test will detect the bad sample since the flow rate will be 0 l/min.Leak test will detect the bad samples since the chamber will not be thermoformed and consequently, the leak test will fail or even will not start.The root cause of the defect may be related to defective injectors.A situation analysis (sa# mps-19-1349-sa) was initiated for the injector complaints with further details related to the investigation: ¿it was observed that lubrication in the membrane pocket and cannula may have migrated into the cannula and potentially occluded the flow location.The batches that demonstrated difficulty in aspirating were then evaluated for lubrication consistency.Several batches demonstrated similar gell like appearance and have been placed on a global hold.Remaining batches were not placed on global hold because they didn¿t demonstrate difficulty in aspiration.¿ if protectors were used with defective injectors, occlusion may avoid the properly work of the protector chamber.

Event Description

It was reported that a bd phaseal optima protector (p20-o) expansion chamber did not deflate.A plug was noticed in the expansion chamber.

• Brand Name: BD PHASEAL OPTIMA PROTECTOR (P20-O)
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8355706
• MDR Text Key: 140010496
• Report Number: 3003152976-2019-00169
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 00382905150647
• UDI-Public: 00382905150647
• Combination Product (y/n): N
• PMA/PMN Number: K181221
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 515064
• Device Lot Number: 1807701
• Date Manufacturer Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other