MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE FLUSH

Catalog Number 306546

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

Patient Problems Respiratory Distress (2045); Sweating (2444)

Event Date 05/01/2018

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 on two separate occasions, thirty minutes after receiving a flush from a bd posiflush¿normal saline syringe, a patient experienced ¿a severe reaction including coughing, couldn't breathe and cold sweats¿.The patient went to the emergency room on both occasions but was told that nothing could be determined.The patient has ¿requested and is waiting for approval to be tested for serratia¿.

Manufacturer Narrative

Investigation summary: dhr/bhr review: there was no documentation of issues for the complaint of batch 7348542 during this production run.Investigation comments: all our inspections and testing performed while manufacturing this batch were accepted.No rejections were documented.Controls in place, at the manufacturing site: bioburden tested on a weekly basis.An overkill sterilization process is used.Environmental testing within the filling area is done on a biweekly basis.The sterilization process is challenged and re-qualified annually.The solution is filtered twice before it is filled in syringes (note: once when transferring to the hold tank and again at the fill machine).Endotoxin testing is performed on each batch.Fill room operators are trained and qualified on gowning for the fill room environment on an annual basis.Weekly bioburden testing on the components used to assemble the syringes.Continuous online monitoring of the wfi water quality (note: this is for toc and conductivity, not microbial - weekly bioburden and endotoxin testing of the usp purified water and wfi systems.Weekly endotoxin testing of the pure steam system.Each sterilizer is thoroughly validated before used for posiflush sterilization.Update.Jun05, 2018.Four (4) samples were received.They are in their sealed packaging flow wrap.They all have the plunger rod-rubber stopper, tip cap, and saline solution.The barrel label confirms the lot# 7348542.Samples will be sent to a lab for testing.Note: these four(4) samples are the same for the complaints (b)(4).Investigation conclusion: root cause could not be determined.There were no qns issued during the production of this batch listed in the complaint.All inspections and testing were accepted during the production of this batch.Update.Jun05, 2018.The four (4) samples received will be sent for lab testing.This report will be updated when the lab results are available.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7523681
• MDR Text Key: 108605098
• Report Number: 1911916-2018-00228
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• Combination Product (y/n): N
• PMA/PMN Number: K141311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 306546
• Device Lot Number: 7348542
• Date Manufacturer Received: 05/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention