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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. PROTECTOR P55; INTRAVASCULAR ADMINISTRATION SET
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BECTON DICKINSON, S.A. PROTECTOR P55; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 515117
Device Problem Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 11/18/2020
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
 
Event Description
It was reported that protector p55 leaked.The following information was provided by the initial reporter: the customer reported as follows: we use assembly fixture.After preparation as usual, the hcp aspirated endoxan (anticancer agent) into a syringe and then found leakage.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-01-06.H6: investigation summary: one protector connected to a vial was returned to our quality team for investigation.The product was visually inspected, no damage or defects were observed on the protector or membrane of the vial stopper and the needle of the protector penetrated the rubber stopper properly.Functional testing was performed, liquid inside the syringe could successfully move to the vial and back to the syringe without issue and no leakage was observed.Leakage testing is performed for all lots during manufacturing to ensure the quality of the membrane.As lot information for this incident was not available, a device history review could not be performed.Based on the investigation results, we are not able to identify a root cause at this time.
 
Event Description
It was reported that protector p55 leaked.The following information was provided by the initial reporter: the customer reported as follows: we use assembly fixture.After preparation as usual, the hcp aspirated endoxan (anticancer agent) into a syringe and then found leakage.
 
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Brand Name
PROTECTOR P55
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key11061226
MDR Text Key227970875
Report Number3003152976-2020-00578
Device Sequence Number1
Product Code ONB
UDI-Device Identifier30382905151171
UDI-Public30382905151171
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 02/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number515117
Device Catalogue Number515117
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2021
Date Manufacturer Received02/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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