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

Catalog Number 306575

Device Problem Product Quality Problem (1506)

Patient Problem Reaction (2414)

Event Date 04/20/2018

Event Type  Injury  

Manufacturer Narrative

Initial reporter e-mail: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

"site has a patient experiencing unique medical concern of unclear provenance/etiology.This item is one of the supply items which may be contributing.Would like an analysis of the product for purity/adulterant." it was reported that the homecare patient experienced a reaction when using the bd posiflush¿ sp syringe.At this time the client is unable to elaborate further information regarding the complaint.An investigation is currently ongoing regarding cultures and tests performed on the patient.Found during use.

Manufacturer Narrative

Investigation summary: five (5) samples were received for evaluation by one of our quality engineers.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# 7271954.Samples were sent to the lab for further testing.The lab testing results were received.The samples were tested for endotoxin, ph, sterility and heavy metals.All results were compliant with the product specification and passed testing.A device history review was completed and there was no documentation of issues for the complaint of batch 7271954 during this production run.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.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 for injection) water quality (note: this is for toc (total organic carbon) and conductivity, not microbial - weekly bioburden and endotoxin testing of the usp (united states pharmacopeia) purified water and wfi systems.Weekly endotoxin testing of the pure steam system.Each sterilizer is thoroughly validated before use for posiflush sterilization.Capa not required for this event.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD POSIFLUSH¿ SP SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7580068
• MDR Text Key: 110507936
• Report Number: 1911916-2018-00269
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 306575
• Device Lot Number: 7271954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Date Manufacturer Received: 05/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other