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 Reaction (2414); No Code Available (3191)

Event Date 03/13/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 during use of the bd posiflush¿ normal saline syringe the customer experienced an allergic reaction.¿the customer reported an adverse reaction during a mucosal flush.Caused burning to esophagus.¿ there was no report medical intervention required.

Manufacturer Narrative

Three representative samples were returned to bd for evaluation.A quality engineer was able to perform a quality check on them and found each to be within specification.Then, the samples were sent to the lab to be evaluated.The samples were put through an endotoxin, ph, subvisible particulate, and environment test and were found to have passed each test.Therefore, a root cause could not be determined based off of the representative samples and the lab results.Dhr/bhr review there was no documentation of issues for the complaint of batch 7240665 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.Root cause could not be determined as all representative samples tested within specifications.Capa not required for this event.

• 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: 7364221
• MDR Text Key: 103268743
• Report Number: 1911916-2018-00124
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/17/2018

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
• Device Operator: Other
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 306546
• Device Lot Number: 7240665
• Initial Date Manufacturer Received: 03/13/2018
• Initial Date FDA Received: 03/22/2018
• Supplement Dates Manufacturer Received: 03/13/2018
• Supplement Dates FDA Received: 04/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other