MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. SYRINGE 10ML SALINE XS

Catalog Number 306572

Device Problem Delivered as Unsterile Product (1421)

Patient Problem Sepsis (2067)

Event Date 09/21/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the patient developed sepsis after using syringe 10ml saline xs.The following information was provided by the initial reporter: we have a customer complaint about the following product: ref 306572 / lot 0154145 the patient has developed sepsis after connecting the nutritional solution.We ask that the batch of bd posiflush be examined to determine if it could have been contaminated in order to rule it out as the cause.We ask for feedback after checking the batch.

Event Description

It was reported that the patient developed sepsis after using syringe 10ml saline xs.The following information was provided by the initial reporter: we have a customer complaint about the following product: ref (b)(4) / lot 0154145 the patient has developed sepsis after connecting the nutritional solution.We ask that the batch of bd posiflush be examined to determine if it could have been contaminated in order to rule it out as the cause.We ask for feedback after checking the batch.

Manufacturer Narrative

H6: investigation summary: a device history record review was performed for provided lot number 0154145 and the review did not reveal any detected quality issues during the production process that could have directly contributed to this reported incident.During the production process and during final inspection of the product, the sterile barrier integrity is confirmed at several points, endotoxin bioburden tests are taken to ensure sterility, and environmental monitoring of the saline fill room is performed bi-weekly.The lab results for this process were reviewed and all of the testing in place ensured that the product was fit for its intended use and met the standard requirements for the product.There is no evidence that posiflush syringe was responsible for the patient¿s infection.

• Brand Name: SYRINGE 10ML SALINE XS
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 10659915
• MDR Text Key: 214793674
• Report Number: 9616657-2020-00161
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 306572
• Device Lot Number: 0154145
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other