MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%

Catalog Number 306572

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Renal Failure (2041)

Event Date 01/14/2019

Event Type  Injury  

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8242797, medical device expiration date: 2021-08-31, device manufacture date: 2018-08-30.Medical device lot #: 8270683, medical device expiration date: 2021-08-31, device manufacture date: 2018-09-27.(b)(6).Device evaluated by mfr: 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 while using bd posiflush¿ xs pre-filled flush syringe nacl 0.9%, patient felt unwell, and was exacerbating chronic obstruction pulmonary symptoms, and temperature was increasing to 38c on (b)(6) 2019.Patient received 10 days course of antibiotic and steroids.Blood culture results were shown that patient experienced acute kidney injury and likely infection.Patient was advised to attend hospital.The following information was provided by the initial reporter: ¿ we have been informed of the following adverse event whereby the patient concerned reported to be feeling unwell on (b)(6) 2019; from the information obtained the patient involved had a recent hospital admission with an exacerbation of copd.The patient attended gp appointment on the (b)(6) 2019 with symptoms of a exacerbation of copd.Patient commenced on 10 day course of antibiotics and steroids on (b)(6) 2019.Upon calea nursing visit ((b)(6) 2019) - patient temperature reading of 38c; parenteral nutrition was not connected as blood cultures was required to be taken for cvc line.Results of blood cultures has since been received and showed aki and likely infection.Patient was advised to attend hospital - no further information has been received on patients' outcome following hospital admission.¿.

Manufacturer Narrative

H.6.Investigation summary: the non-conformances were reviewed for these batches, and there was no record of non-conformance which could contribute to the complaint verbatim reported by the customer.There is no evidence that posiflush syringe was responsible for this reaction/infection.A potential contributory factor maybe other medicinal products in use or administered at the time the patient¿s port was flushed.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/infection 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.

Event Description

It was reported that while using bd posiflush¿ xs pre-filled flush syringe nacl 0.9%, patient felt unwell, and was exacerbating chronic obstruction pulmonary symptoms, and temperature was increasing to 38c on (b)(6) 2019.Patient received 10 days course of antibiotic and steroids.Blood culture results were shown that patient experienced acute kidney injury and likely infection.Patient was advised to attend hospital.The following information was provided by the initial reporter: ¿ we have been informed of the following adverse event whereby the patient concerned reported to be feeling unwell on (b)(6) 2019; from the information obtained the patient involved had a recent hospital admission with an exacerbation of copd.The patient attended gp appointment on the (b)(6) 2019 with symptoms of a exacerbation of copd.Patient commenced on 10 day course of antibiotics and steroids on (b)(6) 2019.Upon calea nursing visit (b)(6) 2019) - patient temperature reading of 38c; parenteral nutrition was not connected as blood cultures was required to be taken for cvc line.Results of blood cultures has since been received and showed aki and likely infection.Patient was advised to attend hospital - no further information has been received on patients' outcome following hospital admission.¿.

• Brand Name: BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: FLUSH SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8487366
• MDR Text Key: 141091420
• Report Number: 9616657-2019-00171
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306572
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other