MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P50; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515105

Device Problem Moisture Damage (1405)

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

Event Date 06/28/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.(b)(6).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 the bd phaseal¿ protector p50 had liquid in expansion chamber.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Correction: due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacturer: no.

Event Description

It was reported that the bd phaseal¿ protector p50 had liquid in expansion chamber.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Investigation summary: four picture samples were received for evaluation by our quality engineer.Upon inspection of the picture samples, liquid was observed within the expansion chamber.As a lot number was not available for this incident, a production history review could not be completed and additional retained samples could not be investigated.If the protector is used more than once, liquid may accumulate within the protector and oversaturate the filter.If the filter becomes oversaturated, a pressure will be created that prevents the proper release of air to the expansion chamber.This same pressure may occur if liquid accumulates in the internal face of the vial rubber stopper.There is no evidence of any failure during the manufacturing process as the lot number is unknown.Based on the above information, an exact cause for the liquid in the expansion chamber cannot be identified.Based on the frequency of the defect and taking into account that a failure in process couldn't be confirmed, no corrective action is needed.

Event Description

It was reported that the bd phaseal¿ protector p50 had liquid in expansion chamber.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD PHASEAL¿ PROTECTOR P50
• 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: 7719412
• MDR Text Key: 115369424
• Report Number: 3003152976-2018-00309
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 30382905151058
• UDI-Public: 30382905151058
• Combination Product (y/n): N
• PMA/PMN Number: K123213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515105
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 07/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other