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

Catalog Number	306424
Health Effect - Clinical Codes	Respiratory Distress (2045); Reaction (2414); Sweating (2444)
Date of Event	05/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is intended to report 1 of the 2 events described in the event.Another mdr will be filed for the 2nd incident.(2nd event submitted with mdr report# 1911916-2018-00230) the customer's address is unknown.Unknown, (b)(6), 0000 usa has been used as a default.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
¿it was reported that on two occasions ((b)(6)), after 30 minutes of pushing iv saline, patient experienced a severe reaction (coughing, couldn't breathe, cold sweats).Patient also used heparin flush but thinks the issue was from the saline more so than the heparin.Patient went to the er on both occasions and was told that nothing was able to be determined.Er checked the patient's lungs, checked for embolism, etc.¿ there was no additional specific information on the medical interventions received.
Additional Manufacturer Narrative
(b)(6).
Additional Manufacturer Narrative
Dhr/bhr review : there was no documentation of issues for the complaint of batch 716087n during this production run.There was no documentation of issues for the complaint of batch 723060n 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.Five (5) 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 shows the lot# 723060n.This is a different batch # than the one reported.Samples will be sent to a lab for testing.Note: these five(5) samples are the same for complaint (b)(4) and (b)(4) product within specification? yes? no? 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 five (5) samples received will be sent for lab testing.This report will be updated when the lab results are available.Capa not required for this event.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 five (5) samples received will be sent for lab testing.This report will be updated when the lab results are available.

• Brand Name: BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGES
• Common Device Name: HEPARIN FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7519613
• Report Number: 1911916-2018-00229
• Device Sequence Number: 1529432
• Product Code: NZW
• UDI-Device Identifier: 30382903064244
• UDI-Public: 30382903064244
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K090680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/27/2018

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 306424
• Device Lot Number: 716087N
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 05/01/2018; 05/01/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 05/31/2018; 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention