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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 Delivered as Unsterile Product (1421)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/15/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9235406, medical device expiration date: 2022-07-31, device manufacture date: 2019-08-23, medical device lot #: 9351570, medical device expiration date: 2022-11-30, device manufacture date: 2019-12-17, medical device lot #: 9255893, medical device expiration date: 2022-08-31, device manufacture date: 2019-09-12.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 liquid had seeped through the top web of the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% packaging before use.Lot#'s 9235406, 9351570, and 9255893 were reported to have been involved in this event, but it is unknown how many occurrences happened within each.The following information was provided by the initial reporter, translated from french to english: "our production department informs me of tasks present on the blisters of the syringes in reference 306572.".
 
Event Description
It was reported that liquid had seeped through the top web of the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% packaging before use.Lot#'s 9235406, 9351570, and 9255893 were reported to have been involved in this event, but it is unknown how many occurrences happened within each.The following information was provided by the initial reporter, translated from french to english: "our production department informs me of tasks present on the blisters of the syringes in reference (b)(4).".
 
Manufacturer Narrative
Investigation summary: a device history record review was performed for provided lot numbers 9351570, 9235406, and 9255893 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, one picture sample was provided for evaluation by our quality engineer team.The picture sample did reveal foreign matter on the product packaging; however, the lot number of the defective product pictured could not be confirmed.It is possible that the foreign matter was a result of the steam sterilization process.The integrity of the product and the sterile barriers would not be affected by this staining.These spots appear only on the outside of the packaging and do not permeate in any way onto the product.Furthermore, microbial permeability testing, cytotoxicity testing, and testing for residual solvents and volatile species has been completed on the packages displaying the brownish stain.The testing confirmed that they do not present any risk to the use of the product and have no impact on the effectiveness, sterility, quality or safety of bd posiflush¿ xs 10ml saline flush syringe.Our quality team will continue to monitor the production process for signs of this potential defect and any emerging trends.
 
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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 Key10026983
MDR Text Key204184947
Report Number9616657-2020-00069
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 05/26/2020
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 Catalogue Number306572
Device Lot NumberSEE SECTION H.10.
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/15/2020
Initial Date FDA Received05/05/2020
Supplement Dates Manufacturer Received04/15/2020
Supplement Dates FDA Received05/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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