MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE; FLUSH SYRINGE- HEPARIN

Catalog Number 306424

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fever (1858); Nausea (1970); Vomiting (2144); Alteration In Body Temperature (2682)

Event Date 05/10/2018

Event Type  Injury  

Manufacturer Narrative

The date received by manufacturer has been used for this field.Investigation summary: no samples were available to bd for evaluation.Therefore, a quality engineer was unable to perform a thorough investigation regarding the reported reaction.However, an engineer was able to review the inspections performed at the manufacturing facility and found no rejections.Bd has controls in place to reduce any chance of contamination.There are weekly bioburden tests, an overkill sterilization process, biweekly environmental testing within the filling area, the solution is filtered twice before the syringes are filled, once when transferring from the hold tank and again at the fill station, endotoxin testing performed on each batch and the pure steam system, continuous online monitoring of the wfi water quality and each sterilizer is thoroughly validated before being used for posiflush sterilization.However, without a sample to investigate bd was unable to determine a possible root cause for this issue.A device history review was performed on the reported lot and it revealed zero documented issue found during this production run.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.Investigation conclusion: dhr/bhr review there was no documentation of issues for the complaint of batch # 732597n during this production run.Investigation comments: all our inspections 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.Product within specification? yes / no.Root cause description: root cause could not be determined.There were no qns issued during the production of this batch # listed in the complaint.All inspections were accepted during the production of this batch.There was no issue documented.Root cause is unknown.Rationale: capa not required for this event.

Event Description

It was reported that the customer experienced nausea/ vomiting, clammy pale chills and low fever while using the bd posiflush heparin lock flush syringe.Found during use.The customer consulted with his physician dr (b)(6) and was given nausea medication and instructed to go to the emergency room if symptoms get worse.

Manufacturer Narrative

Additional information received from customer; "i am happy to inform that my husband (b)(6) is now an outpatient at home and is doing well.The heparin i used to flush his pic-line seems to have had no ill effects on (b)(6).".

• Brand Name: BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE
• Type of Device: FLUSH SYRINGE- HEPARIN
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7557848
• MDR Text Key: 109695433
• Report Number: 1911916-2018-00246
• Device Sequence Number: 1
• Product Code: NZW
• UDI-Device Identifier: 00382903064243
• UDI-Public: 00382903064243
• Combination Product (y/n): N
• PMA/PMN Number: K090680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Patient Family Member or Friend
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 306424
• Device Lot Number: 732597N
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention