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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%; SALINE VASCULAR ACCESS FLUSH
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BECTON, DICKINSON AND CO. BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%; SALINE VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 306572
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 08/24/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Ha device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% packaging was "bent into a banana shape", which pierced through the top web seal due to the tension of the damage.This was found with 5 units before use.The following information was provided by the initial reporter: "as just discussed on the phone, your product posiflush (ref 306572 with batch/lot 0167451) has a serious sterility problem.The product seems to have been subjected to a considerable vacuum during sterilization.All packaging has contracted and is bent into a banana shape.Due to the resulting tension, the packaging on the paper top web is always pierced in the area of the retaining plate.After 100% visual inspection, up to 5 products are non-sterile in a 30-packaging unit.This corresponds to a dramatic reject rate of 16.67%.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 9/16/2020.H.6.Investigation: a device history record review was performed for provided lot number 0167451 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, both picture and physical samples were returned for evaluation by our quality engineer team.Through examination of the samples, package damage was observed.This issue has been investigated with engineering leadership; however, at this point a single cause has not been determined.A corrective and preventive action plan, capa#1833142, has been initiated to further investigate this issue and prevent its recurrence.The current focus of the investigation is on the handling and packaging process of the blister packages.
 
Event Description
It was reported that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% packaging was "bent into a banana shape", which pierced through the top web seal due to the tension of the damage.This was found with 5 units before use.The following information was provided by the initial reporter: "as just discussed on the phone, your product posiflush (ref 306572 with batch/lot 0167451) has a serious sterility problem.The product seems to have been subjected to a considerable vacuum during sterilization.All packaging has contracted and is bent into a banana shape.Due to the resulting tension, the packaging on the paper top web is always pierced in the area of the retaining plate.After 100% visual inspection, up to 5 products are non-sterile in a 30-packaging unit.This corresponds to a dramatic reject rate of 16.67%.".
 
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Brand Name
BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
Type of Device
SALINE VASCULAR ACCESS FLUSH
Manufacturer (Section D)
BECTON, DICKINSON AND CO.
donore road
drogheda
MDR Report Key10537660
MDR Text Key216397650
Report Number9616657-2020-00149
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Type of Report Initial,Followup
Report Date 10/14/2020
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 Date05/31/2023
Device Catalogue Number306572
Device Lot Number0167451
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2020
Initial Date Manufacturer Received 08/24/2020
Initial Date FDA Received09/15/2020
Supplement Dates Manufacturer Received08/24/2020
Supplement Dates FDA Received10/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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