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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL SECONDARY SET (C66); PHASEAL -ADMINISTRATION SET
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BECTON DICKINSON, S.A. BD PHASEAL SECONDARY SET (C66); PHASEAL -ADMINISTRATION SET Back to Search Results
Catalog Number 515316
Device Problem Complete Blockage (1094)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/02/2020
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.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.
 
Event Description
It was reported that bd phaseal secondary set (c66) was clogged.The following information was provided by the initial reporter: "the following has been left behind for a while due to covid, but we regularly have a secondary set c66 that we cannot aspirate after connecting to the iv bag.Nothing can be pulled out of the iv bag or added to the iv bag via the connector after spiking the iv bag.I have put 1 example aside if you need this for research (but i have previously passed on this complaint i thought).The line i have kept is therefore a secondary set c66 with reference 515316, lot number ta11382 and expiry date 2022-09-30.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 7/20/2020.H.6.Investigation: one sample was returned to our quality team for investigation.Upon inspecting the product, functional testing was performed and it was verified that liquid could not pass through the filter.A device history review was performed and found no non-conformances associated with this issue during the production of lot ta11382.Four retained samples from the same lot were used for additional evaluation.In all cases the product functioned properly and no issues related to flow were identified.After further evaluation of the returned sample, the filter line was identified to be obstructed.This component is provided by an external supplier whom we have notified of this incident.Through their investigation they observed the port was blocked.A review of the device records for the impacted component did not reveal any non-conformities related to this failure.A direct issue could not be identified.H3 other text : see h.10.
 
Event Description
It was reported that bd phaseal secondary set (c66) was clogged.The following information was provided by the initial reporter: "the following has been left behind for a while due to covid, but we regularly have a secondary set c66 that we cannot aspirate after connecting to the iv bag.Nothing can be pulled out of the iv bag or added to the iv bag via the connector after spiking the iv bag.I have put 1 example aside if you need this for research (but i have previously passed on this complaint i thought).The line i have kept is therefore a secondary set c66 with reference 515316, lot number ta11382 and expiry date 2022-09-30.".
 
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Brand Name
BD PHASEAL SECONDARY SET (C66)
Type of Device
PHASEAL -ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key10313563
MDR Text Key202173967
Report Number3003152976-2020-00319
Device Sequence Number1
Product Code LHI
Combination Product (y/n)N
PMA/PMN Number
NA
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 10/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/30/2022
Device Catalogue Number515316
Device Lot NumberTA11382
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2020
Initial Date Manufacturer Received 07/02/2020
Initial Date FDA Received07/23/2020
Supplement Dates Manufacturer Received10/28/2020
Supplement Dates FDA Received10/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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