MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P50J; ADMINISTRATION SET

Catalog Number 515111

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

No lot # provided.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that before use a bd phaseal¿ protector p50j malfunctioned as "connected with n35.When preparing endoxan (lot:4449), the bladder didn't inflate and hcp drew the drug by force." there was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

H.6.Investigation summary: the sample was evaluated by (b)(6) lab.According to its report, the expansion chamber worked properly.Dhr cannot be reviewed as the lot is unknown.It is recommended to properly follow the instructions explained in the ifu.Root cause cannot be confirmed.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 in according to ph-300 current version.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 centred in the protector housing, correctly sealed and free of holes or damages.Visual inspection of the filter is performed to verify that is centred 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.Hydrofobic filter leakage is performed to verify that no leaks are present in the filter.Conclusion: according to (b)(6), the defect cannot be confirmed: the expansion chamber worked properly.Dhr cannot be reviewed as the lot is unknown.It is recommended to properly follow the instructions explained in the ifu.Root cause cannot be confirmed.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).

• Brand Name: BD PHASEAL¿ PROTECTOR P50J
• Type of Device: ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7537484
• MDR Text Key: 109239609
• Report Number: 3003152976-2018-00209
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515111
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 05/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other