Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR (P14); INTRAVASCULAR ADMINISTRATION SET
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR (P14); INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 515100
Device Problem Occlusion Within Device (1423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/22/2018
Event Type  malfunction  
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 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.
 
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 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD PHASEAL¿ PROTECTOR (P14)
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key7652591
MDR Text Key113004563
Report Number3003152976-2018-00260
Device Sequence Number1
Product Code ONB
UDI-Device Identifier00382905151002
UDI-Public00382905151002
Combination Product (y/n)N
PMA/PMN Number
K123213
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 07/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/28/2022
Device Catalogue Number515100
Device Lot Number1703017
Date Manufacturer Received06/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-