Ten potential lot numbers were provided for this incident.
The information for each lot number is as follows: medical device lot #: 732011c, medical device expiration date: 11/15/2020, device manufacture date: 11/16/2017.
Medical device lot #: 731812c, medical device expiration date: 11/13/2020, device manufacture date: 11/14/2017.
Medical device lot #: 722612b, medical device expiration date: 8/13/2020, device manufacture date: 8/14/2017.
Medical device lot #: 729812c, medical device expiration date: 10/24/2020, device manufacture date: 10/25/2017.
Medical device lot #: 725111b, medical device expiration date: 9/7/2020, device manufacture date: 9/8/2017.
Medical device lot #: 711112c, medical device expiration date: 4/20/2020, device manufacture date: 4/21/2017.
Medical device lot #: 716111b, medical device expiration date: 6/9/2020, device manufacture date: 6/10/2020.
Medical device lot #: 711511c, medical device expiration date: 4/24/2020, device manufacture date: 4/25/2017.
Medical device lot #: 707212b, medical device expiration date: 3/12/2020, device manufacture date: 3/13/2017.
Medical device lot #: 715811b, medical device expiration date: 6/6/2020, device manufacture date: 6/7/2017.
A device evaluation is anticipated, but has not yet begun.
Upon completion of the investigation, a supplemental report will be filed.
|
It was reported that a (b)(6) female with a diagnosis of hodgkin¿s lymphoma 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 3 ml bd¿ pre-filled normal saline syringe, in 3 ml syringe.
*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.
|