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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 02/10/2018

Event Type  Injury  

Manufacturer Narrative

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 infections associated with central lines and the use of a 10 ml bd posiflush¿ normal saline syringe, in 10 ml syringe were being investigated by the fda.There was no evidence that the bd device is implicated but all sources and common products are being investigated.There was no report of death, serious injury, or medical intervention.The patient involved was a (b)(6) old male picu patient with picc, tetralogy of fallot, blood (+) for serratia marcescens on (b)(6) 2018.The patient was not intubated at the time of (+) blood cultures and the 10 ml bd posiflush¿ normal saline syringe, in 10 ml syringe was used only as an iv flush.

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) ne plant.In addition, the posiflush product produced within (b)(4) is terminally sterilized through steam sterilization which is re-qualified 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 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 this batch # listed in the complaint.All inspections were accepted during the production of these batch #s.There was no issue documented.

• 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
• MDR Report Key: 7488153
• MDR Text Key: 107440257
• Report Number: 1911916-2018-00226
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065470
• UDI-Public: 30382903065470
• Combination Product (y/n): N
• PMA/PMN Number: K141311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 306547
• Device Lot Number: 8024680
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 MO