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

Catalog Number 306546

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Examination of the product involved may provide clarification as to the cause for the reported failure.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.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.Additionally, controls in place, at the manufacturing site are as follows: 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.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Investigation conclusion: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Examination of the product involved may provide clarification as to the cause for the reported failure.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.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Root cause description: undetermined.Rationale: no batch #/sample available.

Event Description

It was reported that after use of the bd posiflush¿ normal saline syringe the patient had an allergic reaction.The patient was admitted to the hospital to have a colonoscopy.The saline solution was used to sanitize the access.After using the syringe to clear the access, the patient had the following symptoms: hypotension, skin pallor, tremors, tachycardia and fever of 38.3º.Patient with adverse reactions after use.Suspected bacteremia, with fever.Customer was not able to provide more information.The client requested the limit of bacterial endotoxins (le) of the sample.Information received by email: the batch number is 8107669.The hospitalization of the patient occurred because the incident with the bd posiflush.The patient was discharged from the hospital on (b)(6) 2019.There was no sequel in the patient, when the patient came out of from the hospital , he was totally recovered.(b)(6) was not notified.Only one patient had the reaction.

Event Description

It was reported that after use of the bd posiflush¿ normal saline syringe the patient had an allergic reaction.The patient was admitted to the hospital to have a colonoscopy.The saline solution was used to sanitize the access.After using the syringe to clear the access, the patient had the following symptoms: hypotension, skin pallor, tremors, tachycardia and fever of 38.3º.Patient with adverse reactions after use.Suspected bacteremia, with fever.Customer was not able to provide more information.The client requested the limit of bacterial endotoxins (le) of the sample.Information received by email: the batch number is 8107669.The hospitalization of the patient occurred because the incident with the bd posiflush.The patient was discharged from the hospital on (b)(6) 2019.There was no sequel in the patient, when the patient came out of from the hospital , he was totally recovered.Anvisa was not notified.Only one patient had the reaction.

Manufacturer Narrative

The following fields have been updated due to additional information: d.3.Medical device manufacturer: bd medical (bd west) medical surgical.G.1.Manufacturing location: bd medical (bd west) medical surgical.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8391635
• MDR Text Key: 137879250
• Report Number: 2243072-2019-00404
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 306546
• Device Lot Number: 8107669
• Date Manufacturer Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention