MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR (P21); INJECTOR

Catalog Number 515102

Device Problems Fluid/Blood Leak (1250); Connection Problem (2900)

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

Event Date 10/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Investigation: 1 sealed samples has been received.It was connected to a vial and no leak has been found.Hydrophobic filter test was performed and not leak was found.1 retained sample has been tested: no leak between the protector and the vial was found, no leak trough hydrophobic filter either.Inspections and tests in manufacturing area for protectors: protector housing were manufactured by nolato supplier.Currently, they are molded in bd san agustin plant.Visual inspections and critical dimensions for protector housing parts are performed according to ph-300 current version.Snap fit diameter is verified with a go/no go caliber.During assembly process, the operator performs the following inspections and tests according to ph-302 current version:.It is verified that expansion film of the bladder is centered in the protector housing, correctly sealed and free of holes or damages.Visual inspection of the filter is performed to verify that is centered in the protector cavity, welded in a right position and free of holes between the filter and filter cover.Overpressure test is performed to verify that the expansion film of the bladder can resist certain pressure.-film breakage test: the expansion film of the bladder must break at minimum pressure (0,8 bar).It is verify if the break is produced in the sealing area of the film or between the protector and the film.- hydrophobic filter leakage is performed to verify that no leaks are present in the filter.The sample received does not show any type of leak (between protector-vial/ trough hydrophobic filter).The retained sample shows no defects.No qn¿s or other events that could produce the defect has been found during dhr review.To take into account: in case of the protector is used more than once, liquid of the vial can be accumulated over the filter oversaturating it.An overpressure is created around the hydrophobic filter and no air can be released to the expansion chamber.This can produces significant resistance to inject the air into the vial.On the other hand, in case of liquid was accumulated in the internal face of the vial rubber stopper, it can pass through the protector cannula and be accumulated over filter causing the same effect (resistance to inject the air and leaks into the expansion chamber in case of overpressure).It is recommended to carefully follow the instructions explained in ifu.Keeping the vial upright, push the air or the diluent into the vial.The expansion chamber will inflate.- invert the system and withdraw the drug into the syringe.The expansion chamber will deflate.If the vial is inverted when the air it pushed inside, it will be created an overpressure which probably caused a leakage trough the hydrophobic filter.As previously explained, once the filter is wet there is a resistance to inject the air.Based on the low severity and frequency of the defect (according to ps-001) and acceptable results for sample received/retained samples and manufacturing process, it was determined that no capa is required.

Event Description

It was reported that during drug aspiration, a bd phaseal¿ protector (p21) leaked under the connection site with vial.There was no report of exposure, injury or medical interventions.

• Brand Name: BD PHASEAL¿ PROTECTOR (P21)
• Type of Device: INJECTOR
• 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 ; 8015652845
• MDR Report Key: 7186710
• MDR Text Key: 97783271
• Report Number: 3003152976-2017-00238
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 30382905151027
• UDI-Public: 30382905151027
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K123213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 515102
• Device Lot Number: 1610008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2016
• 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
• Patient Outcome(s): Other