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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL SECONDARY SET (C62); PHASEAL ADMINISTRATION SET
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BECTON DICKINSON, S.A. BD PHASEAL SECONDARY SET (C62); PHASEAL ADMINISTRATION SET Back to Search Results
Catalog Number 515312
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/13/2019
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 has been reported that one bd phaseal secondary set (c62) has been found with a broken tip before use.The following has been provided by the initial reporter: connector broke off from y site.The connector broke off from the y site during priming of the c62.Sample contaminated with saline.
 
Event Description
It has been reported that one bd phaseal secondary set (c62) has been found with a broken tip before use.The following has been provided by the initial reporter: connector broke off from y site.The connector broke off from the y site during priming of the c62.Sample contaminated with saline.
 
Manufacturer Narrative
H.6.Investigation: one sample and one photo were provided to our quality team for investigation.The final product for lot ta11680 is assembled and packaged at a supplier site.We notified the supplier of the reported issue and provided the product for evaluation.Upon visually inspecting the sample that was received, a crack was observed in the y-site.Retained samples were used for additional evaluation, there were no visual defects noted and all product was manufactured according to specification.All testing was reviewed for the reported lot, including leakage, torque, and inspection results with no issues identified related to the reported malfunction.Based on available information, excessive force by the operator when connecting the connector piece to the y-site is believed to be the potential root cause for this incident.Capa#1382647 was initiated.H3 other text : see h.10.
 
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Brand Name
BD PHASEAL SECONDARY SET (C62)
Type of Device
PHASEAL ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key9536516
MDR Text Key190341891
Report Number3003152976-2019-00900
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
Report Date 02/14/2020
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 Date03/31/2023
Device Catalogue Number515312
Device Lot NumberTA11680
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/13/2019
Initial Date FDA Received12/31/2019
Supplement Dates Manufacturer Received12/13/2019
Supplement Dates FDA Received02/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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