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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); INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON, S.A. BD PHASEAL SECONDARY SET (C62); INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 515312
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/10/2020
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: two photos were provided to our quality team for investigation.The final product for lot ta11878 is assembled and packaged at a supplier site.Upon visual inspection, no protective cap was observed on the end of the luer connection, verifying the reported incident.Five retained samples were used for additional evaluation, there were no defects noted, all protective caps were properly in place, and product was manufactured according to specification.Product undergoes inspections throughout manufacturing, inspection results were reviewed for the reported lot with no issues identified related to the reported malfunction.Based on available information, we were not able to identify a definitive root cause related to the manufacturing process at this time.Investigation conclusion: the final product secondary set c62 is not assembled/packaged in (b)(4) facilities.The information of this complaint was sent to the subcontractor (sendal) to perform the investigation (sc-047-20).According to their report rc-2020-131 (received on april 22nd, 2020), after the investigation, the dhr review (no issues detected during production) and the complaint trend history (not related complaints), it is concluded that it is not possible to determine the root cause with accuracy.Note that the issue was detected after opening the packaging, so it is possible that the protective cap was missing between the opening and the use of the set.Furthermore, five samples retained in bd (b)(4) facilities were subjected to visual inspection.The visual inspection on unused samples retained at bd (b)(4) facilities cannot replicate the issue detected by the customer as the protective cap was in place.The complaint trend history was review for a one-year period and several additional complaints were found related to the affected reference c62.Consider the current complaint is the first one related to a missing protective cap root cause description: after the investigation, the dhr review (no issues detected during production) and the complaint trend history (not related complaints), it is concluded that it is not possible to determine the root cause with accuracy.Note that the issue was detected after opening the packaging, so it is possible that the protective cap was missing between the opening and the use of the set.Furthermore, five samples retained in bd (b)(4) facilities were subjected to visual inspection.The visual inspection on unused samples retained at bd (b)(4) facilities cannot replicate the issue detected by the customer as the protective cap was in place.Rationale: capa is not required in this instance as the issue could not be replicated without sample, without evidences after the dhr review and after visual inspection of the retained samples.
 
Event Description
It was reported that the bd phaseal¿ secondary set (c62) was missing its protective cap before use.The following information was provided by the initial reporter: "c62 missing protective cap.After opening the c62 from packaging, the pharmacist noticed that the protective cap at the end of the luer connection is missing.".
 
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Brand Name
BD PHASEAL SECONDARY SET (C62)
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key10083076
MDR Text Key212147401
Report Number3003152976-2020-00221
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/22/2020
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 Health Professional
Device Expiration Date06/30/2023
Device Catalogue Number515312
Device Lot NumberTA11878
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/11/2020
Initial Date FDA Received05/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/24/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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