MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 3 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, 30 USP UNITS/3 ML; PREFILLED HEPARIN FLUSH SYRINGE

Catalog Number 306413

Device Problem Microbial Contamination of Device (2303)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 08/24/2018

Event Type  Death  

Manufacturer Narrative

No samples were provided for evaluation.There was no documentation of issues for the complaint of this batch # during this production run.All our inspections performed while manufacturing this batch # was 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 for injection) water quality (note: this is for toc (total organic carbon) and conductivity, not microbial.- weekly bioburden and endotoxin testing of the (b)(4) purified water and wfi systems.- weekly endotoxin testing of the pure steam system.- each sterilizer is thoroughly validated before use for posiflush sterilization.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.Investigation conclusion: this is the first complaint for lot # 814601n for this type of defect or symptom.There was no documentation of issues for the complaint of batch # 814601n during this production run.Root cause description: undetermined.

Event Description

A patient's son reported that his father passed away on (b)(6) 2018.The cause of death was reported as a heart attack related to a blood clot.The patient also had a history of septic shock, (b)(6) from gangrene in (b)(6) and (b)(6), a partial foot amputation, a heart attack three months prior to his death with one stent placed in his left leg and two stents placed in his heart, and was hospitalized for one month.The patient's son indicated that these events occurred while the patient was using a 3 ml bd posiflush¿ heparin lock flush syringe, 30 usp units/3 ml (10 usp units/ml).

• Brand Name: 3 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, 30 USP UNITS/3 ML
• Type of Device: PREFILLED HEPARIN FLUSH SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7866934
• MDR Text Key: 119922974
• Report Number: 1911916-2018-00530
• Device Sequence Number: 1
• Product Code: NZW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 306413
• Device Lot Number: 814601N
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention