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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P50J CLOSED SYSTEM DRUG DELIVERY

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BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P50J CLOSED SYSTEM DRUG DELIVERY Back to Search Results
Catalog Number 515111
Device Problem Inflation Problem (1310)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/31/2018
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation and/or device history review, a supplemental report will be filed.
 
Event Description
It was reported that the bladder of a bd phaseal¿ protector p50j didn¿t inflate. There was no report of exposure, injury or medical intervention.
 
Manufacturer Narrative
Investigation summary: three unused sample units were received for evaluation by our quality engineer team. Upon inspection of the samples, no defects were observed. The expansion chambers of all three units expanded properly. A device history record review did not reveal any deviations or non-conformances during the production of the provided lot number that could have contributed to the reported issue. Based on the investigation results, a cause for the reported defect could not be determined. It is important to note that if the protector is used more than once, the filter may become oversaturated and prevent proper air release to the expansion chamber. The same resistance can occur if liquid accumulates in the internal face of the vial rubber stopper. This is a single use device. If the protector is used more than once, liquid of the vial can be accumulated over the filter oversaturating it. An overpressure is created around the hydrophobic filter and no air can be released to the expansion chamber. This can produces significant resistance to inject the air into the vial. If liquid was accumulated in the internal face of the vial rubber stopper, it can pass through the protector cannula and be accumulated over filter causing the same effect (resistance to inject the air and leaks into the expansion chamber in case of overpressure). It is recommended to carefully follow the instructions explained in the ifu. Conclusion: this complaint is related to another complaint in which retained samples of the involved lot (#1702025) were taken for evaluation and no issues were found. It is not possible to establish the root cause of the defect, as no issues were found in retained and received samples. Based on the low severity and frequency of the defect, it was determined that no capa is required.
 
Event Description
It was reported that the bladder of a bd phaseal¿ protector p50j didn¿t inflate. There was no report of exposure, injury or medical intervention.
 
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Brand NameBD PHASEAL¿ PROTECTOR P50J
Type of DeviceCLOSED SYSTEM DRUG DELIVERY
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key7616090
MDR Text Key111921116
Report Number3003152976-2018-00247
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup,Followup
Report Date 08/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/31/2022
Device Catalogue Number515111
Device Lot Number1702025
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/19/2018 Patient Sequence Number: 1
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