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

Catalog Number 515111

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 12/07/2018

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 during use of the bd phaseal¿ protector p50j foreign matter was found in the vial and drew it in the syringe.

Manufacturer Narrative

Investigation summary: one sample protector unit was received for evaluation by our quality engineer team.Dhr could not be carried out as the lot number is unknown.Investigation conclusion: through visual inspection of the sample, grey and elastic foreign matter was observed.There were no defects found in the needles of the protector nor in the needle of the additionally returned injector product.Root cause description: coring from the membrane may occur due to fragmentation caused by multiple injections or excessive welding of the membrane.Coring of the rubber stopper may result depending on the stopper quality, the design and dimensions of the needles used, or if a poor connection of the protector occurs.Based on the type of foreign matter found, it is possible that it resulted from the rubber stopper.As there are several contributing factors for coring, an exact cause for this incident could not be determined.Rationale: a corrective and preventive action plan has been initiated to further investigate this issue and prevent its reoccurrence.Complaints received for this device and defect will be closely monitored by our quality team.

Event Description

It was reported that during use of the bd phaseal¿ protector p50j foreign matter was found in the vial and drew it in the syringe.

• Brand Name: BD PHASEAL¿ PROTECTOR P50J
• Type of Device: PHASEAL ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8190784
• MDR Text Key: 131378877
• Report Number: 3003152976-2018-00560
• Device Sequence Number: 1
• Product Code: LHI
• 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: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 12/07/2018
• Supplement Dates FDA Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other