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 Dyspnea (1816); Itching Sensation (1943); Rash (2033)

Event Date 07/04/2018

Event Type  Injury  

Manufacturer Narrative

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 the bd posiflush¿ xs pre-filled flush syringe when used to administered normal saline flush after changing the patient's bionectar, the patient seemed to have an adverse reaction with various symptoms including a rash on her arms, itchiness and difficulties in breathing.There was no report of exposure.

Manufacturer Narrative

Due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: required intervention; hospitalization.Device single use?: no.Device returned to manufacture: no.Investigation summary: lot number 8081834 for product 306572 was provided for evaluation by our quality engineer.A device history record review did not reveal any issues during the production of lot number 8081834 that could have contributed to the reported issue.All tests results for the provided lot number were reviewed and no non-conformances were found.Samples were not available for return for this incident and retained samples of the same lot number were not available within the manufacturing facility.There is no evidence to support that the posiflush syringe was responsible for the reported reaction.A potential contributory factor may have been the other medicinal products in use or administered at the time the patient's port was flushed with the posiflush product.Complaints for this lot and issue will be closely monitored.

Event Description

It was reported that the bd posiflush¿ xs pre-filled flush syringe when used to administered normal saline flush after changing the patient's bionectar the patient seemed to have an adverse reaction with various symptoms including a rash on her arms, itchiness and difficulties in breathing.There was no report of exposure.

• Brand Name: BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE
• Type of Device: SALINE FLUSH
• 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: 7724050
• MDR Text Key: 115188543
• Report Number: 9616657-2018-00035
• 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: foreign,other,user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 306572
• Device Lot Number: 8081834
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2018
• 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): Hospitalization; Required Intervention