• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS UNSPECIFIED BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE PREFILLED HEPARIN FLUSH SYRINGE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON MEDICAL SYSTEMS UNSPECIFIED BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE PREFILLED HEPARIN FLUSH SYRINGE Back to Search Results
Catalog Number UNKNOWN
Device Problems Nonstandard Device (1420); Microbial Contamination of Device (2303)
Patient Problems Bacterial Infection (1735); Hematoma (1884); Inflammation (1932); Swelling (2091)
Event Date 03/13/2018
Event Type  Injury  
Manufacturer Narrative
Medical device expiration date: unknown. Fda notified?: the fda was made aware of this incident via voluntary medwatch 5076827. This information was communicated to bd on 5/11/2018 by the fda. 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
The following information was reported to bd via mw5076827: the pt is a (b)(6) with severe hemophilia a with an implantable port for administration of recombinant clotting factor. He developed bacteremia with serratia marcescens and had to undergo port removal. Typically, his port is infused with clotting factor several times a week and the port is flushed with heparin prior to de-access. We received notification from bd regarding a heparin recall that included lot numbers which had been given to our pt. The recall was due to concern regarding serratia marcescens contamination. The pt has severe hemophilia with an inhibitor. He was receiving regular factor infusions (immune tolerance induction, daily factor infusions plus daily infusions of factor for prophylaxis). He developed a hematoma over his port in (b)(6), which eventually resolved. He continued to have problems with his port throughout the winter. The area was frequently inflamed and swollen. It was thought that he either had an unresolved hematoma or had developed an infection as his port is critical for his medication administration. We worked to keep his port in while awaiting the port area to heal (when we¿re presuming it was a hematoma), he did not receive factor infusions and developed a joint bleed which required hospital adminstration in (b)(6) 2018. He then developed a blister like lesion over his port in (b)(6) 2018 which prompted the port removal. The removal of the post resulted in losing iv access for tis pt and a switch to a different product to treat his hemophilia-hemlibra. The admission for his port removal was 3 days. The pt was treated with oral antibiotics after initial iva antibiotics. If he would not have had an infection in his port, he would have remained on his factor and not switched medications (to a new medicine that was newly fda approved but my plan was to wait for a few months of add¿l data before switching products). Further, if he would not have had a port infection, i would have kelp the port in for easy access for at least 2 more years. *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
As both a lot number and sample were unavailable for this incident, a full investigation consisting of a sample analysis and a device history record review could not be completed. Prior to (b)(6) 2018, there was no trend for infection regarding the bd franklin products. Upon the increase of infection reports beginning in (b)(6) 2018, a corrective and preventive action plan was initiated to address the issue. A review of all lot sterility testing performed for product released between (b)(6) 2015 and (b)(6) 2018 confirmed that no organism growth was identified for any lots released during the shelf life of this product. A direct causation between the reported infections and the bd franklin product has not been identified. Investigation conclusion: unknown ¿ lot number was not provided. Prior to the report of infection evaluated in (b)(4), there was no trend for infection cases reported for (b)(6) product. This complaint is part of a new trend which began in (b)(6) 2018. (b)(4) was initiated to address this issue. As no lot number was provided, a dhr review could not be completed. Quantity of retained samples used for testing: 0 ¿ although retain samples are available for all lots manufactured in franklin, as the lot number was not provided, retain samples were not tested. A review of all lot sterility testing performed for product released between april 2015 & may 2018 confirmed that no organism growth was identified for any lots released during the shelf-life of this product. The root cause analysis of the reported infection cases under (b)(4) has not identified a direct causation between the infections and the (b)(4) product.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNSPECIFIED BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE
Type of DevicePREFILLED HEPARIN FLUSH SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
9630 south 54th street
franklin WI 53132
MDR Report Key7550718
MDR Text Key109494977
Report Number2134319-2018-00023
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 06/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/29/2018 Patient Sequence Number: 1
-
-