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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 FLUSH
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BECTON, DICKINSON AND CO. BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%; SALINE FLUSH Back to Search Results
Catalog Number 306572
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Malaise (2359)
Event Date 02/21/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).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 bd posiflush¿ xs pre-filled flush syringe nacl 0.9% a patient had a lot of pain when the flush was inserted.Batch is unknown but likely to be 8270683 as we have supplied just this lot on multiple deliveries in 2019.It was stated: "on speaking to the nurse she reports that the patient had reported a lot of pain around her chest and clavicle area non the saline flush been given.The nurse has stopped the flush and the pain has stopped slightly but continues to sting and feel as if something is spreading under the skin, they attempted another 1ml but this occurred again and they have stopped.There is no redness or swelling to the site at present and the patient denies any shortness of breath or chest pain but confirms she has a high heart rate, she is able to feel this in her temple and has done for a few days on and off, and feels generally unwell.I have advised the nurse to clamp the line using the blue clamps as close to the exit site as possible as there may be an internal line fracture and have advised nothing further is put through the line and the patient attends hospital this evening for assessment.The nurse has reiterated this to the patient but as she has a lot going on at home at present and an appointment with her gastro nutrition team at (b)(6) hospital tomorrow she has declined and confirmed she will attend in the morning instead.The patient has full mental capacity and is able to relay the information back with an understanding of the potential dangers of not attending this evening.I have advised that should she develop any further symptoms such as chest pain, shortness of breathe, neck pain, further rapid pule rate or dry cough the patient attends hospital via 999 immediately this evening, she has agreed to this and is happy to do so should any of these symptoms occur.I have spoken to the medical registrar at (b)(6) infirmary in the absence of a gastro registrar been on call, who has taken the details and will log them for the nutrition and gastro team to be aware of for the patients visit tomorrow but has also agreed with my advice that she should ideally attend this evening to be assessed.".
 
Event Description
It was reported that bd posiflush¿ xs pre-filled flush syringe nacl 0.9% a patient had a lot of pain when the flush was inserted.Batch is unknown but likely to be 8270683 as we have supplied just this lot on multiple deliveries in 2019.
 
Manufacturer Narrative
H.6.Investigation summary: dhr: complaint trending review of the lot for this issue reveals this is the third complaint.The non-conformances were reviewed for this batch, and there was no record of non-conformance which could contribute to the complaint verbatim reported by the customer.No sample was received for evaluation.There is no evidence that 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.Conclusion(s): based on the information provided, it is more probable than not that the symptoms described may be an allergic reaction; however, it is highly improbable that this reaction was produced by the normal saline in the bd posiflush product.During the period 2017-2019, there are no other adverse customer complaint trends for the complaint category of allergic reaction, apart from fresenius kabi uk.There are no known allergies to normal saline, either topical or within the body.It is most likely that whatever fluid was in the iv line prior to flushing contained inadequately flushed medication or glucose from previous treatments.
 
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Brand Name
BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
Type of Device
SALINE FLUSH
Manufacturer (Section D)
BECTON, DICKINSON AND CO.
donore road
drogheda
MDR Report Key8414387
MDR Text Key138644056
Report Number9616657-2019-00142
Device Sequence Number1
Product Code NZW
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 03/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2021
Device Catalogue Number306572
Device Lot Number8270683
Date Manufacturer Received02/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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