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

Catalog Number 306572

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

Patient Problems Fever (1858); Nausea (1970)

Event Date 01/09/2019

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).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 after using bd posiflush¿ xs pre-filled flush syringe, patient experienced symptoms of nausea, slight increase in body temperature.There was unknown cause of pyrexia.Patient was advice to go to hospital.Customer¿s verbatim: ¿ we have received an adverse event report on (b)(6) 2019 concerning the aforementioned product, whereby patient experienced symptoms of nausea and slight increase in body temperature - no known cause for pyrexia.Patient advised to attend hospital; no further information has been obtained in regards to patient outcome following a& e visit.Product - 306572 pfs 0.9% p/flush xs saline.Batch - 8242797 / 8270683.Samples: no use: 10 ml to flush line before and 20 ml after each infusion as directed.¿.

Manufacturer Narrative

Investigation summary: dhr: 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.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.

Event Description

It was reported that after using bd posiflush¿ xs pre-filled flush syringe, patient experienced symptoms of nausea, slight increase in body temperature.There was unknown cause of pyrexia.Patient was advice to go to hospital.Customer¿s verbatim: ¿ we have received an adverse event report on (b)(6) 2019 concerning the aforementioned product, whereby patient experienced symptoms of nausea and slight increase in body temperature - no known cause for pyrexia.Patient advised to attend hospital; no further information has been obtained in regards to patient outcome following a& e visit.Product - 306572 pfs 0.9% p/flush xs saline.Batch - 8242797 / 8270683.Samples: no use: 10 ml to flush line before and 20 ml after each infusion as directed.¿.

• Brand Name: BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8436697
• MDR Text Key: 139417885
• Report Number: 9616657-2019-00155
• Device Sequence Number: 0
• 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: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 04/17/2019

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: Lay User/Patient
• Device Catalogue Number: 306572
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 03/20/2019
• Supplement Dates Manufacturer Received: 03/04/2019
• Supplement Dates FDA Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other