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

Catalog Number 306547

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 04/18/2018

Event Type  Injury  

Manufacturer Narrative

Two potential lot numbers were provided for this incident.The information for each lot number is as follows: medical device lot #: 8018983; medical device expiration date: 1/31/2021; device manufacture date: 1/18/2018.Medical device lot #: 8044680; medical device expiration date: 1/31/2021; device manufacture date: 2/13/2018.Investigation: no samples were provided for evaluation.There was no documentation of issues for the complaint of batch #s 8018983 and 8044680 during this production run.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 usp (united states pharmacopeia) purified water and wfi systems.Weekly endotoxin testing of the pure steam system.Each sterilizer is thoroughly validated before use for posiflush sterilization.A three year review of complaints, environmental monitoring results, water testing results, and quality notifications have confirmed that the serratia marcescens organism has not been recovered in the (b)(4) plant.In addition, the posiflush product produced within (b)(4) is terminally sterilized through steam sterilization which is requalified annually.Furthermore, there is no morphological evidence of serratia marcescens ability to survive the steam conditions1 used to sterilize the posiflush product manufactured in the (b)(4) plants.For validation, bd (b)(4) & bd (b)(4) uses the spore forming, rod-shaped, gram-positive, thermophile geobacillus stearothermophillus as our biological indicator, along with bacillus atrophaeus.The formation of endospores has not been reported in any species of serratia, thus its resistance to steam sterilization is scientifically remote, further it is a motile organism with growing temperatures ranging from 5¿40 °c, which is well below our >121 °c processing temperatures.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.Root cause is undetermined.A capa has been opened for further investigation.

Event Description

It was reported that a (b)(6) year old female with a diagnosis of hodgkin¿s lymphoma and a picc line in place had a positive blood culture for serratia marcescens on (b)(6) 2018.The patient was treated and discharged.The pfge patterns for this incident are indistinguishable from the original co outbreak pattern.The device implicated with this incident is a 10 ml bd posiflush¿ normal saline syringe, in 10 ml syringe.

• Brand Name: 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE, IN 10 ML SYRINGE
• Type of Device: PREFILLED SALINE 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: 7599328
• MDR Text Key: 111013827
• Report Number: 1911916-2018-00291
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065470
• UDI-Public: 30382903065470
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 306547
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 16 YR