MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD¿ POSIFLUSH¿ SALINE XS 10 ML; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306572

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

Patient Problem Unspecified Infection (1930)

Event Date 10/18/2022

Event Type  Injury  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.There were multiple lot numbers reported to be potentially involved.The information for each additional lot number is as follows: medical device lot #: 9232938; medical device expiration date: 31jul2022; device manufacture date: 20aug2019; medical device lot #: 9235407; medical device expiration date: 31jul2022; device manufacture date: 23aug2019; medical device lot #: 9182101; medical device expiration date: 30jun2022; device manufacture date: 01jul2019; medical device lot #: 9248167; medical device expiration date: 31aug2022; device manufacture date: 05sep2019.Investigation summary: a device history record review was completed for provided material number 306572 and potential lot numbers 9224747, 9232938, 9235407, 9182101, and 9248167.The review did not reveal any possible non-conformances during the production process that could have contributed to the reported defect.All relevant in process and finished product inspections performed were found to be within specification.The test results ensured that the products were fit for their intended use and met the standard requirements for the product, as verified by the facility microbiologist¿s evaluation.The lots provided were manufactured in 2019.Please note that bd posiflush has an expiry date or 2 years and 11 months from the date of manufacturing.As samples were unavailable for return, a thorough sample analysis could not be performed.

Event Description

It was reported while using bd¿ posiflush¿ saline xs 10 ml an infection occurred.There was no report of patient impact.The following information was provided by the initial reporter: we have received a complaint in relation to product bd306572 lot numbers 9224747, 9232938, 9235407, 9182101, 9248167.The customer states that their daughter experienced a line infection after using the product, they are unsure which lot number it belongs to but have advised of all the lot numbers they had at the time.

• Brand Name: BD¿ POSIFLUSH¿ SALINE XS 10 ML
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15789774
• MDR Text Key: 303573079
• Report Number: 9616657-2022-00038
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/02/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 306572
• Device Lot Number: 9224747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2019
• 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