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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ DRUG VIAL ACCESS DEVICE
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BECTON DICKINSON, S.A. BD PHASEAL¿ DRUG VIAL ACCESS DEVICE Back to Search Results
Catalog Number 515064
Device Problem Contamination of Device Ingredient or Reagent (2901)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/13/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that unspecified bd¿ connector had foreign matter.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: ¿material no.: unknown, batch no.: unknown.It was reported that the device introduced clear particles in the syringe.Per complaint form: the following email message was received: we seem to be having another issue come up in the last couple days.As seen in this picture, it looks as if there is a clear particle in the syringe that contains cyclophosphamide.It is unclear where this came from.The product was clear prior to drawing up.We used the phaseal adaptor and an injector when drawing up.This was also seen with two other drugs (herceptin and paclitaxel) over the past couple days but i was just made aware now.The lot and expiry for the injector is 1806708, exp 11/30/2019.We do not have the lot and expiry for the adaptor as this was added to the cyclophosphamide yesterday or the day before.".
 
Manufacturer Narrative
Investigation: no samples or photos that display the reported condition were provided for investigation.A device history review was performed for reported lot 1807701, no deviations or non-conformances related to the reported issue were identified during the manufacturing process.Fragmentation testing is performed for protectors to evaluate the quantity and type of particulate matter generated by the injector when mated with other components after multiple activations.The results of the fragmentation testing for reported lot were reviewed and found to be within specification.Based on the available information we are not able to determined a root cause at this time.
 
Event Description
It was reported that bd phaseal¿ drug vial access device had foreign matter.This occurred on 3 occasions.It was reported that the device introduced clear particles in the syringe.Per complaint form: the following email message was received: we seem to be having another issue come up in the last couple days.As seen in this picture, it looks as if there is a clear particle in the syringe that contains cyclophosphamide.It is unclear where this came from.The product was clear prior to drawing up.We used the phaseal adaptor and an injector when drawing up.This was also seen with two other drugs (herceptin and paclitaxel) over the past couple days but i was just made aware now.The lot and expiry for the injector is 1806708 exp 11/30/2019.We do not have the lot and expiry for the adaptor as this was added to the cyclophosphamide yesterday or the day before.
 
Event Description
It was reported that bd phaseal¿ drug vial access device had foreign matter.This occurred on 3 occasions.It was reported that the device introduced clear particles in the syringe.Per complaint form: the following email message was received: we seem to be having another issue come up in the last couple days.As seen in this picture, it looks as if there is a clear particle in the syringe that contains cyclophosphamide.It is unclear where this came from.The product was clear prior to drawing up.We used the phaseal adaptor and an injector when drawing up.This was also seen with two other drugs (herceptin and paclitaxel) over the past couple days but i was just made aware now.The lot and expiry for the injector is 1806708 exp 11/30/2019.We do not have the lot and expiry for the adaptor as this was added to the cyclophosphamide yesterday or the day before.
 
Manufacturer Narrative
The following fields have been updated with additional information: b.5.Describe event or problem: it was reported that bd phaseal¿ drug vial access device had foreign matter.This occurred on 3 occasions.It was reported that the device introduced clear particles in the syringe.Per complaint form: the following email message was received: we seem to be having another issue come up in the last couple days.As seen in this picture, it looks as if there is a clear particle in the syringe that contains cyclophosphamide.It is unclear where this came from.The product was clear prior to drawing up.We used the phaseal adaptor and an injector when drawing up.This was also seen with two other drugs (herceptin and paclitaxel) over the past couple days but i was just made aware now.The lot and expiry for the injector is 1806708 exp 11/30/2019.We do not have the lot and expiry for the adaptor as this was added to the cyclophosphamide yesterday or the day before.D.1.Medical device brand name: bd phaseal¿ drug vial access device.D.2.Medical device type: onb.D.2.Common device name: drug vial access device.D.3.Medical device manufacturer: san agustin.D.4.Medical device catalog #: 515064.D.4.Medical device expiration date: 2019-06-30.D.4.Medical device lot #: 1807701.D.4.Unique identifier (udi) #: (b)(4).G.1.Manufacturing location: san agustin.G.5.Pma/510(k)#: k181221.H.4.Device manufacture date: 2018-07-06.
 
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Brand Name
BD PHASEAL¿ DRUG VIAL ACCESS DEVICE
Type of Device
DRUG VIAL ACCESS DEVICE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix NJ 07417
MDR Report Key8464729
MDR Text Key145400830
Report Number2243072-2019-00602
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
PMA/PMN Number
K181221
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 06/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/30/2019
Device Catalogue Number515064
Device Lot Number1807701
Was Device Available for Evaluation? No
Date Manufacturer Received03/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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