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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); IV ADMINISTRATION SET
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BECTON DICKINSON, S.A. BD PHASEAL SECONDARY SET (C62); IV ADMINISTRATION SET Back to Search Results
Catalog Number 515312
Device Problem Packaging Problem (3007)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/17/2019
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that an unspecified number of bd phaseal secondary set (c62) experienced a damaged/open unit/package where sterility was compromised noted prior to use.The following information was provided by the initial reporter: now this lot shows that there are many packages without product at all or then a part of the product is outside the package.
 
Manufacturer Narrative
Investigation summary: one sample was provided to our quality team for investigation.A device history review was performed and found no non-conformances associated with this issue during the production of this batch.The final product for lot ta10414 is assembled and packaged at a supplier site.We provided the product sample to the supplier for evaluation and they were able to verify the product was outside the blister pack which resulted in improper sealing of the blister package.The set is manually assembled and inserted into the machine, which seals the paper to form the unit packaging.Through their investigation it was determined that this issue likely occurred as a result of improper placement of the device into the blister machine by the operator which led to poor sealing of the blister pack.Improvements have been made on the blister machine to avoid reoccurrence of this issue, the reported lot was manufactured prior to these improvements being implemented.Complaints for this device and defect will continue to be monitored by our quality team for signs of emerging trends.Machine is considered as one of the sources of the problem reported by the customer at the issue is generated during the unitary packaging of the set into the blister machine.Manpower is considered at the root cause of the problem according to the available information.The operator placed incorrectly the set into the blister machine, result of a punctual operator´s carelessness due to the mold design related to the cavity.Conclusion: after the investigation, it is concluded that the most probably root cause is that the cavity of the mold is not suitable enough to support long sets, like iv sets and/or extension set and then, the operator has more difficult the manual task of introduce the set into the cavity.Capa is not required in this instance as an internal capa has already been implemented (capa-2018/055) and the blister machine has already been modified to include specific moulds for each type of product (the mould for phaseal products began to be used in the middle of january), in such a way that it avoids the equipment being trapped when it comes to sealing the blister.In this way, it avoids breakages in the equipment by not being trapped and ensures the correct welding of the blister.
 
Event Description
It was reported that an unspecified number of bd phaseal secondary set (c62) experienced a damaged/open unit/package where sterility was compromised noted prior to use.The following information was provided by the initial reporter: now this lot shows that there are many packages without product at all or then a part of the product is outside the package.
 
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Brand Name
BD PHASEAL SECONDARY SET (C62)
Type of Device
IV ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key8755789
MDR Text Key150023980
Report Number3003152976-2019-00438
Device Sequence Number1
Product Code LHI
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,health professional,o
Type of Report Initial,Followup
Report Date 08/08/2019
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 Date06/30/2021
Device Catalogue Number515312
Device Lot NumberTA10414
Initial Date Manufacturer Received 06/17/2019
Initial Date FDA Received07/02/2019
Supplement Dates Manufacturer Received06/17/2019
Supplement Dates FDA Received08/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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