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

Catalog Number 306572

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

Patient Problems Malaise (2359); Shaking/Tremors (2515)

Event Date 03/29/2019

Event Type  Injury  

Manufacturer Narrative

Investigation summary: no samples were returned, but retain samples were obtained, and repeat endotoxin testing was performed on samples from the lot number provided.All results were within the acceptance criteria.The dhr for the provided lot was reviewed and the microbiological and chemical release criteria were comprehensively satisfied.Complaint trending review of the lot for this issue reveals this is the first 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.Investigation conclusion: 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.Root cause description: during the period of 2017 - 2019, there are no other adverse customer complaint trends for the complaint category of allergic reaction, apart from fresenius kabi (b)(4).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.A review of the bd manufacturing records of the lot number associated with the product in question did not identify any other complaints of allergic reaction.It was also noted that the product was used approximately 2 years before its expiry date.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that after using the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% for "parenteral nutrition infusion", the patient felt "unwell" and a "little shaky".However, there were no signs of infection nor was there medical intervention reported.The following information was provided by the initial reporter: "we have been informed of the following ae incident on (b)(6) 2019 whereby patient reports to feel unwell following parenteral nutrition infusion (symptoms: little shaky).No recent changes to regime and no signs of infection.".

• Brand Name: BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: PRE-FILLED SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8523974
• MDR Text Key: 142263308
• Report Number: 9616657-2019-00189
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 306572
• Device Lot Number: 8353641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other