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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cyanosis (1798); Swelling (2091); Low Oxygen Saturation (2477)
Event Date 02/09/2020
Event Type  Injury  
Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9248167, medical device expiration date: 2022-08-31, device manufacture date: 2019-09-05.Medical device lot #: 9224747, medical device expiration date: 2022-07-31, device manufacture date: 2019-08-12.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 the patient was admitted to the hospital due to "oxygen levels of 30% on removing bi-pap machine" and "blue swollen lips" when the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was used to perform a flush on them."taurolock 3ml amps" was also used on the patient.Lot#'s 9248167 and 9224747 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: "patient admitted to hospital on (b)(6) 2020; due to oxygen levels of 30% on removing bi-pap machine with blue swollen lips.Potential for allergic reaction to the saline (flushes and saline bag) and taurolock 3ml amps; the products have been taken to the hospital for testing.No confirmation on cause of allergic reaction yet.".
 
Manufacturer Narrative
H.6.Investigation summary a device history record review was performed for provided lot numbers 9224747 & 9248167.The review did not reveal any detected quality issues during the production process of either lot number that could have contributed to this reported incident.As a sample was unavailable for this incident, further investigation could not be completed.At this time there is no evidence to confirm that the posiflush syringe was responsible for this reaction.A potential contributory factor maybe other medicinal products in use or administered at the time the patient¿s port was flushed.Our quality team will continue to monitor the production process for signs of this potential defect and other emerging trends.
 
Event Description
It was reported that the patient was admitted to the hospital due to "oxygen levels of 30% on removing bi-pap machine" and "blue swollen lips" when the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was used to perform a flush on them."taurolock 3ml amps" was also used on the patient.Lot#'s 9248167 and 9224747 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: "patient admitted to hospital on (b)(6) 2020; due to oxygen levels of 30% on removing bi-pap machine with blue swollen lips.Potential for allergic reaction to the saline (flushes and saline bag) and taurolock 3ml amps; the products have been taken to the hospital for testing.No confirmation on cause of allergic reaction yet.".
 
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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 Key9780384
MDR Text Key184157805
Report Number9616657-2020-00037
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Type of Report Initial,Followup
Report Date 03/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
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 02/12/2020
Initial Date FDA Received03/03/2020
Supplement Dates Manufacturer Received02/12/2020
Supplement Dates FDA Received03/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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