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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 10/19/2020
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 #: 0118620, medical device expiration date: 2023-04-30, device manufacture date: 2020-04-27, medical device lot #: 0126426, medical device expiration date: 2023-04-30, device manufacture date: 2020-05-05.Medical device lot #: 0160013 medical device expiration date: 2023-05-31 device manufacture date: 2020-06-08 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 439 bd posiflush¿ xs pre-filled flush syringes nacl 0.9% from lot 0118620, 27 syringes from lot 0126426, and 68 syringes from lot 0160013 had poor perforation between their packaging units.The following information was provided by the initial reporter: "(1) pcs with packaging damaged/broken while separating the syringes due to imperfections of the dotted separation line, can have a negative impact on the product sterility when operators detach the single blister from the strip.For this issue bd is working on the process implementation and to increase quality of packaging.(2) pcs with red or dark stains on the packaging "cosmetic spot" due to sterilization process which the manufacturer can consider a feature of the product that cannot currently be eliminated and not in compliance for use the product in the assembled kits.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-11-26.H6: investigation summary: a device history record review was performed for provided lot number 0118620 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, perforation slits were observed in good condition on the product packages.Based on the investigation results, a cause related to the manufacturing process could not be determined for this incident.Previous investigation findings have determined that an incorrect method of separation may cause defects such as this reported incident.It is recommended that the blister packages are separated on a horizontal plant.H3 other text : see h10.
 
Event Description
It was reported that 439 bd posiflush¿ xs pre-filled flush syringes nacl 0.9% from lot 0118620, 27 syringes from lot 0126426, and 68 syringes from lot 0160013 had poor perforation between their packaging units.The following information was provided by the initial reporter: "(1) pcs with packaging damaged/broken while separating the syringes due to imperfections of the dotted separation line, can have a negative impact on the product sterility when operators detach the single blister from the strip.For this issue bd is working on the process implementation and to increase quality of packaging.(2) pcs with red or dark stains on the packaging "cosmetic spot" due to sterilization process which the manufacturer can consider a feature of the product that cannot currently be eliminated and not in compliance for use the product in the assembled kits.".
 
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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 Key10833654
MDR Text Key216390306
Report Number9616657-2020-00165
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 02/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2020
Date Manufacturer Received02/25/2021
Patient Sequence Number1
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