MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ XS 10ML PRE-FILLED FLUSH SYRINGE NACL 0.9%

Catalog Number 306572

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

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Swelling (2091)

Event Date 05/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

A patient had an allergic reaction shortly after having her port flushed with a bd posiflush xs 10ml pre-filled flush syringe nacl 0.9%.The patient reported feeling unwell, felt breathless, itchy all over, came out in generalized rash, and had unilateral periorbital swelling.After device usage, the medication was stopped, the port was flushed, and the patient received treatment for an allergic reaction.

Manufacturer Narrative

Results: samples were received.Not decontaminated.Ph & assay completed on returned sample.All results within specification.The dhr was reviewed for this lot (6144642).All test results were within specification, there were no excursions which could have contributed to this issue.Conclusion: bd was not able to duplicate or confirm the customer's indicated failure mode.A root cause was unassignable in this case as all dhr results and test data were within specification.

• Brand Name: BD POSIFLUSH¿ XS 10ML PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: FLUSH 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 ; 8015652845
• MDR Report Key: 6686954
• MDR Text Key: 79070465
• Report Number: 9616657-2017-00004
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 306572
• Device Lot Number: 6144642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2016
• 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): Required Intervention