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 Insufficient Information (3190)

Patient Problems Death (1802); Sepsis (2067)

Event Date 02/19/2018

Event Type  Death  

Manufacturer Narrative

There are multiple potential lot numbers provided for this incident.The information for each lot number is as follows: medical device lot #: 8032588, medical device expiration date: 2/31/2021, device manufacture date: 2/1/2018.Medical device lot #: 7352973, medical device expiration date: 12/31/2020, device manufacture date: 12/18/2017.Medical device lot #: 8018972, medical device expiration date: 12/31/2020, device manufacture date: 1/18/2018.Medical device lot #: 7326845, medical device expiration date: 11/30/2020 , device manufacture date: 11/22/2017.The initial reporter indicated that this incident occurred at (b)(6).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 that on (b)(6) 2018, a 10 ml bd posiflush¿ normal saline syringe, in 10 ml syringe was used on a patient's port.On (b)(6) 2018, the patient had symptoms that were not indicative of infection but blood cultures were drawn from the port.One of the 2 blood cultures turned (b)(6) for serratia marcescens.On (b)(6) 2018, the patient presented with sepsis.The patient had blood cultures drawn when they presented with sepsis on (b)(6) and those cultures were (b)(6) for serratia marcescens.On (b)(6) 2018, the patient died.The case is not yet linked to the cluster of serratia infections that are being investigated by cdc/fda.This is a new case in tn (not one the 4 cases that tn has reported to cdc) with a serratia bloodstream infection with a port and had received heparin among other medications.The pfge pattern for the serratia from this patient is not the same as the 11 cases under investigation with cdc/fda.

Manufacturer Narrative

Correction: type of report: the initial mdr was submitted as a 30-day report.Bd has changed our position on this incident and we are making a correction to report the mdr as a 5-day report.

Manufacturer Narrative

No samples were provided for evaluation.There was no documentation of issues for the complaint of these batch #s during this production run.All our inspections performed while manufacturing these batch #s 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 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) and bd (b)(4) uses the spore forming, rod-shaped, gram-positive, thermophile geobacillus stearothermophilus 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.Product within specification? yes no.Root cause could not be determined.There were no qns issued during the production of these batch #s listed in the complaint.All inspections were accepted during the production of these batch #s.There was no issue documented.Root cause is unknown.

• 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: 7453065
• MDR Text Key: 106247234
• Report Number: 1911916-2018-00189
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2018

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 Catalogue Number: 306547
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 04/23/2018
• Supplement Dates Manufacturer Received: 04/19/2018; 04/19/2018
• Supplement Dates FDA Received: 05/01/2018; 06/11/2018
• 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): Death