MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P14; PHASEAL ADMINISTRATION SET

Catalog Number	515100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported during use that the bd phaseal¿ protector p14 does not fit appropriately into the vial neck and it is not stable, moves and tends to get easily disconnected and cause leakage.No reports of serious injury or medical intervention noted.
Additional Manufacturer Narrative
Results: bd received one unopened sample in support of the customer¿s complaint.Visual inspection shows no defects.The protector fits properly the vial and no leak was found.No quality notifications or other events were found during device history record review (assembly and molding lots evaluated).Several tests and inspections are carried out to avoid faulty parts.Among them, functionality test is performed.During this tests, if protector does not fit the vial, it would be notice by the operator.Conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure mode.The root cause is indeterminate.Based on the low severity and frequency of the defect (according to ps-001), it was determined that no capa is required.

• Brand Name: BD PHASEAL¿ PROTECTOR P14
• Common Device Name: PHASEAL ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7175628
• Report Number: 3003152976-2017-00229
• Device Sequence Number: 868985
• Product Code: ONG
• UDI-Device Identifier: 00382905151002
• UDI-Public: 00382905151002
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2018

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
• Operator of Device: Other
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 515100
• Device Lot Number: 1603035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 01/09/2018
• Supplement Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other