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

Catalog Number	515100
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 that during the transferring of the fluid between the p14 and the n35 they noticed for few bubbles in the syringe with 1ml of fluid and it looks strange.They have noticed few drops on the gloves and also on the outside of bd phaseal¿ protector (p14) components.Found during use.No reports of serious injury or medical intervention noted.
Additional Manufacturer Narrative
Investigation summary: as no physical samples or picture samples were provided for evaluation, a returned sample investigation could not be completed.Retained samples of the reported protector (lot: 1703017) were obtained for evaluation from our manufacturing facility.Upon visual inspection of the retained samples, no defects were observed.The retained samples were then assembled for functionality testing and leakage did not occur.A device history record review did not reveal any non-conformances during the production of the provided lot number that could have contributed to the reported defect of leakage.During the manufacturing assembly process, inspections are performed to detect defective product.Protector housing were manufactured by (b)(4) supplier.Currently, they are molded in bd (b)(4) plant.Visual inspections and critical dimensions for protector housing parts are performed according to current procedure.During assembly process, the operator performs the following inspections and tests according to current procedure: 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.Functionality test is performed to ensure properly work of the protector.Hydrophobic filter leakage is performed to verify that no leaks are present in the filter.For all manufactured lot, leak test is performed according to procedure to confirm that no leaks appear on the membranes.The root cause cannot be established.It was determined that no capa is required.
Event or Problem Description
It was reported that during the transferring of the fluid between the p14 and the n35 they noticed for few bubbles in the syringe with 1ml of fluid and it looks strange.They have noticed few drops on the gloves and also on the outside of bd phaseal¿ protector (p14) components.Found during use.No reports of serious injury or medical intervention noted.

• Brand Name: BD PHASEAL¿ PROTECTOR (P14)
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7652591
• Report Number: 3003152976-2018-00260
• Device Sequence Number: 13865989
• Product Code: ONB
• UDI-Device Identifier: 00382905151002
• UDI-Public: 00382905151002
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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): 07/25/2018

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: 02/28/2022
• Device Catalogue Number: 515100
• Device Lot Number: 1703017
• Initial Date Received by Manufacturer: 06/10/2018
• Supplement Date Received by Manufacturer: 06/10/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 07/30/2018
• 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