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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTORS P53; INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTORS P53; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 515107
Device Problem Unintended Ejection (1234)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/14/2018
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd phaseal¿ protectors p53 leaked.No serious injury or medical intervention was reported.
 
Manufacturer Narrative
One sample unit was received for evaluation by our quality engineer team.Upon visual inspection of the sample, leakage was not observed.The protector was found to properly fit the vial and no visual defects were found in regards to the product components.A device history record review did not reveal any issues during the production of lot number 1503021 that could have contributed to the reported defect.No qn¿s or other issues were found during dhr review.The leak was not confirmed on sample involved in the complaint.No evidences of failure during manufacturing process were found.No root cause found.
 
Event Description
It was reported that bd phaseal protectors p53 leaked.No serious injury or medical intervention was reported.
 
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Brand Name
BD PHASEAL¿ PROTECTORS P53
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key7842453
MDR Text Key119501400
Report Number3003152976-2018-00389
Device Sequence Number1
Product Code ONB
UDI-Device Identifier00382905151071
UDI-Public00382905151071
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 10/02/2018
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
Device Operator Other
Device Expiration Date02/29/2020
Device Catalogue Number515107
Device Lot Number1503021
Initial Date Manufacturer Received 08/15/2018
Initial Date FDA Received09/04/2018
Supplement Dates Manufacturer Received08/15/2018
Supplement Dates FDA Received10/03/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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