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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE; PREFILLED SALINE FLUSH SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE; PREFILLED SALINE FLUSH SYRINGE Back to Search Results
Catalog Number 306500
Device Problems Product Quality Problem (1506); Microbial Contamination of Device (2303)
Patient Problem Unspecified Infection (1930)
Event Date 05/16/2018
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 a patient contracted an infection after using an unspecified bd posiflush¿ normal saline syringe and was placed on antibiotics.The patient indicated that the lot number was 518011c, however this is not a valid lot number according to production records.Out of an abundance of caution and in the interest of public health, bd voluntarily recalled certain lots of bd posiflush¿ heparin lock flush and bd¿ pre-filled normal saline flush syringes due to a potential for contamination with serratia marcescens bacterium.Bd was notified by the u.S.(b)(4) about a potential epidemiological link between catheter related blood stream infections and the s.Marcescens bacterium.Specifically, the (b)(6) identified a potential connection between reports of infection in a small number of patients caused by s.Marcescens across multiple states.(b)(4)¿s initial investigation found that affected patients had received treatment using certain bd flush products.To date, there is no evidence of bd flush product testing positive for this bacterium.Investigations are ongoing by bd, (b)(4).
 
Manufacturer Narrative
Investigation summary: prior to the report of infection evaluated in mps-18-1248-sa, there was no trend for infection cases reported for franklin product.This complaint is part of a new trend which began in april 2018.There were no deviation, non-conformances, or out of specification conditions noted during the manufacture of lot: 718011c.100% of retained samples for the lot (b)(4) units) were visually inspected.No growth was seen (i.E., the solution was clear).Lot: 718011c was manufactured between lots: 716192n and 718091n both of which exhibited no growth during the confirmatory sterility testing.This, in combination with the daily environmental monitoring and original sterility testing for the lot release, provides confidence in the sterility of the complaint lot.A review of all lot sterility testing performed for product released between april 2015 & june 2018 confirmed that no organism growth was identified for any lots released during the shelf life of this product.Investigation conclusion: the root cause analysis of the reported infection cases under capa 350041 has not identified a direct causation between the infections and the bd franklin product.
 
Event Description
It was reported that a patient contracted an infection after using an unspecified bd posiflush¿ normal saline syringe and was placed on antibiotics.The patient indicated that the lot number was 518011c, however this is not a valid lot number according to production records.Out of an abundance of caution and in the interest of public health, bd voluntarily recalled certain lots of bd posiflush¿ heparin lock flush and bd¿ pre-filled normal saline flush syringes due to a potential for contamination with serratia marcescens bacterium.Bd was notified by the u.S.Food and drug administration (fda) and centers for disease control and prevention (cdc) about a potential epidemiological link between catheter related blood stream infections and the s.Marcescens bacterium.Specifically, the fda and cdc identified a potential connection between reports of infection in a small number of patients caused by s.Marcescens across multiple states.Cdc¿s initial investigation found that affected patients had received treatment using certain bd flush products.To date, there is no evidence of bd flush product testing positive for this bacterium.Investigations are ongoing by bd, fda, and cdc.
 
Manufacturer Narrative
The customer provided additional information that the implicated catalog number 306500 and lot number is 718011c for a 10 ml bd¿ pre-filled normal saline syringe, in 10 ml syringe.The customer states that she administers the flush herself with sterile technique assisted by a visiting nurse.The customer also indicated that she had two cellulitis infections that were treated with antibiotics and pain medications and her drain placement for an abdominal abscess as extended from 3-4 weeks to 12 weeks.Medical device brand name: 10 ml bd¿ pre-filled normal saline syringe, in 10 ml syringe medical device catalog #: 306500.Medical device lot #: 718011c.Medical device expiration date: 06/28/2020.Unique identifier (udi): (b)(4).Medical device operator: patient.Unique identifier (udi) # : (b)(4).Device expiration date: 7/3/2017.
 
Event Description
The customer provided additional information that the implicated catalog number 306500 and lot number is 718011c for a 10 ml bd¿ pre-filled normal saline syringe, in 10 ml syringe.The customer states that she administers the flush herself with sterile technique assisted by a visiting nurse.The customer also indicated that she had two cellulitis infections that were treated with antibiotics and pain medications and her drain placement for an abdominal abscess as extended from 3-4 weeks to 12 weeks.
 
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Brand Name
10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE
Type of Device
PREFILLED SALINE FLUSH SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
9630 south 54th street
franklin WI 53132
MDR Report Key7587530
MDR Text Key110636267
Report Number2134319-2018-00040
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K011982
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup
Report Date 08/23/2018
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 Expiration Date06/28/2020
Device Catalogue Number306500
Device Lot Number718011C
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/16/2018
Initial Date FDA Received06/11/2018
Supplement Dates Manufacturer Received05/16/2018
05/16/2018
Supplement Dates FDA Received08/22/2018
08/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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