MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE PREFILLED SALINE FLUSH SYRINGE

Catalog Number 306500

Device Problems Nonstandard Device (1420); Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 03/20/2018

Event Type  Injury  

Manufacturer Narrative

Four lot numbers were provided for this incident. The information for each lot number is as follows: medical device lot #: 715011a; medical device expiration date: 5/29/2020; device manufacture date: 5/31/2017. Medical device lot #: 716411c; medical device expiration date: 6/12/2020; device manufacture date: 6/13/2017. Medical device lot #: 720712c; medical device expiration date: 7/25/2020; device manufacture date: 7/26/2017. Medical device lot #: 723511a; medical device expiration date: 8/22/2020; device manufacture date: 8/23/2017. 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 the cdc confirmed a case of serratia marcescens bloodstream infection from (b)(6) with pfge patterns indistinguishable from the original co outbreak pattern. The patient is a (b)(6) year old male diagnosed with lymphoma and is immunocompromised with an implanted port that was accessed in an outpatient infusion clinic. The patient presented to a hospital with positive serratia marcescens culture on (b)(6) 2018, was treated, and subsequently discharged. The specific treatment provided is unknown. The device implicated with this incident is a 10 ml bd¿ pre-filled normal saline syringe, in 10 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 (b)(4) about a potential epidemiological link between catheter related blood stream infections and the s. Marcescens bacterium. Specifically, the fda and (b)(4) 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, fda, and (b)(4).

• 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
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; 9630 south 54th street; franklin WI 53132
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7541270
• MDR Text Key: 109168163
• Report Number: 2134319-2018-00024
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 306500
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 05/24/2018 Patient Sequence Number: 1