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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 07/27/2020
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 #: 9263969, medical device expiration date: 2022-08-31, device manufacture date: 2019-09-20, medical device lot #: 0035110, medical device expiration date: 2023-01-31, device manufacture date: 2020-02-04, medical device lot #: 0105650, medical device expiration date: 2023-03-31, device manufacture date: 2020-04-14, medical device lot #: 0111366, medical device expiration date: 2023-03-31, device manufacture date: 2020-04-20.A 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 primary packaging of the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was found stained.There were 210 syringes in lot 9263969, 132 syringes in lot 0035110, 133 syringes in lot 0105650, and 196 syringes in lot 0111366 found with this defect.The following information was provided by the initial reporter: "stains on the packaging".
 
Manufacturer Narrative
H.6.Investigation summary a device history record review was performed for provided lot numbers 0111366, 0105650, 0035110, and 9263969.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, eight picture samples were returned for evaluation by our quality engineer team.Through examination of the pictures, brown stains were observed on the product packaging.It has been determined that the stains resulted from the steam sterilization process.The integrity of the product and the sterile barriers have not been affected.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.We are currently exploring several options to reduce and eliminate any brown staining that occurs on the packaging.
 
Event Description
It was reported that the primary packaging of the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was found stained.There were 210 syringes in lot 9263969, 132 syringes in lot 0035110, 133 syringes in lot 0105650, and 196 syringes in lot 0111366 found with this defect.The following information was provided by the initial reporter: "stains on the packaging.".
 
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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 Key10418164
MDR Text Key204044310
Report Number9616657-2020-00125
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 08/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2020
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
Date Manufacturer Received07/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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