MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE FILLED SYRINGE, 10 ML FILL IN 10 ML DIAMETER; FLUSH SYRINGE, SALINE

Catalog Number 306546

Device Problem Device Contamination With Biological Material (2908)

Patient Problems Fungal Infection (2419); Test Result (2695)

Event Date 11/27/2015

Event Type  Injury  

Manufacturer Narrative

Result - a review of the device history record revealed no abnormalities during the manufacture of the reported lot number 5237663.This included a review of the quality notifications, molding, fill room, plunger rod, and case pack checks.A review of the sterilization records revealed no issues.All endotoxin testing and bioburden testing did pass.Conclusion - the suspect device was not returned for evaluation.Bd was not able to duplicate or confirm the customer¿s indicated failure mode.An absolute root cause this incident could not be determined as there were no issues documented that would affect the syringe, the function, or would induce the alleged mold issue.If a sample is returned for evaluation, a supplemental report will be filed upon completion of the investigation.

Event Description

The customer reported a suspected mold contamination from a bd posiflush normal saline filled syringe.The patient's csf removed through the line grew two molds, paecilomyces spp.And possible exophiala spp.The patient was not thought to have been the source of the molds.The patient was initially placed on echinocandin and then later changed to amphotericin for two weeks.There was no adverse patient outcome reported.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE FILLED SYRINGE, 10 ML FILL IN 10 ML DIAMETER
• Type of Device: FLUSH SYRINGE, SALINE
• 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: 5320518
• MDR Text Key: 34197203
• Report Number: 1911916-2015-00006
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/15/2015

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: 08/31/2018
• Device Catalogue Number: 306546
• Device Lot Number: 5237663
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2015
• Initial Date FDA Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention