MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. 10 ML BD POSIFLUSH¿ STERILE FIELD (SF) SALINE SYRINGE, IN 10 ML SYRINGE; PREFILLED SALINE FLUSH SYRINGE

Catalog Number 306553

Device Problem Contamination (1120)

Patient Problems Sepsis (2067); Respiratory Failure (2484)

Event Date 02/19/2018

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that a (b)(6) female patient with a diagnosis of respiratory failure and sepsis 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¿ sterile field (sf) saline syringe, in 10 ml syringe.

Manufacturer Narrative

H.6.Investigation summary: as neither a sample nor a valid lot number for the reported product code (306553) were available for evaluation by our quality engineer team, a three year review of complaints, environmental monitoring results, water test results, and quality notifications was performed.Upon review, the records indicate there were no occurrences of serratia marcescens documented within the (b)(6) manufacturing facility.The (b)(6) manufactured posiflush products are sterilized using moist heat sterilization; a process which is annually re-qualified.There is no morphological evidence that s.Marcescens has the ability to survive the moist heat sterilization process.In addition, s.Marcescens is a mobile organism with growing conditions of 5-40 degrees celsius, which is well below the moist heat sterilization temperature of 121 degrees celsius.A corrective and preventive action plan has been initiated to further investigate and monitor this issue.Investigation conclusion: no sample received.Note: samples unavailable, complaint was not raised on a specific lot number of posiflush sf or sp.Complaint raised in association with an fda investigation of infections in patients with central lines whose treatment involved the use of posiflush sp, sf, and heparin lock syringes.Lot number unknown.Dhr - n/a - lot number unknown.- the provided lot numbers for this complaint were reviewed and concluded not to be manufactured in (b)(6).Manufacturing review: the organism associated with the complaint was identified as serratia marcescens.A review of environmental monitoring data from 2015-2018 and bioburden ids confirmed that the organism has never been recorded at the (b)(6) site.Reference to known issue: (b)(4).Unconfirmed.Investigation comments- n/a (no sample or lot).Root cause: a batch number was not supplied in this instance.However, in accordance with cpr-033, situational analysis, a three year review of complaints, environmental monitoring results, water test results and quality notifications was performed.Records indicate that there were no recorded occurrences of s.Marcescens organism in the (b)(6) plant.In addition, (b)(6) posiflush product is terminally sterilized with moist heat sterilization.The sterilization process is requalified annually to demonstrate sterility assurance level of >10-6.Other action taken: there is no morphological evidence of serratia marcescens ability to survive the moist heat sterilization process.During the validation and annual re-validation of the (b)(6) steam sterilizers, the plant uses spore forming thermophilic gram positive rod shaped geobacillus stearothermophilus s a biological indicator.The formation of endospores has not been reported in any species of serratia, thus its resistance to steam sterilization is scientifically remote.In addition, it is a mobile organism with growing conditions of 5-40 degrees celsius, well below the moist heat sterilization temperature of 121 degrees celsius.Root cause description: root cause: a batch number was not supplied in this instance.However, in accordance with cpr-033, situational analysis, a three year review of complaints, environmental monitoring results, water test results and quality notifications was performed.Records indicate that there were no recorded occurrences of s.Marcescens organism in the (b)(6) plant.In addition, (b)(6) posiflush product is terminally sterilized with moist heat sterilization.The sterilization process is requalified annually to demonstrate sterility assurance level of >10-6.Capa 449645 has been raised to deal with this complaint.

Event Description

It was reported that a 4 year old female patient with a diagnosis of respiratory failure and sepsis 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¿ sterile field (sf) saline syringe, in 10 ml syringe.

• Brand Name: 10 ML BD POSIFLUSH¿ STERILE FIELD (SF) SALINE SYRINGE, IN 10 ML SYRINGE
• Type of Device: PREFILLED SALINE FLUSH SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 7589894
• MDR Text Key: 110751501
• Report Number: 9616657-2018-00030
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065531
• UDI-Public: 30382903065531
• Combination Product (y/n): N
• PMA/PMN Number: K153481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 306553
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR