MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 3ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 10 USP UNITS/ML; PREFILLED HEPARIN FLUSH SYRINGE

Catalog Number	306521
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	03/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Multiple lot number were provided for this incident.The information for each lot number is as follows: medical device lot #: 721481n, medical device expiration date: 2/1/2019, device manufacture date: 8/8/2017.Medical device lot #: 726571n, medical device expiration date: 3/21/2019, device manufacture date: 9/27/2017.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that a patient contacted a serratia marcescens after using a 3 ml bd posiflush¿ heparin lock flush syringe, in 10 ml syringe, 10 usp units/ml.The cdc indicated preliminary information from the mn public health lab shows the pfge of this isolate is a match to the outbreak strain.The cdc received this clinical isolate and plan on repeating the pfge as well.As of (b)(6) 2018 the following clinical information has been provided: the patient has a double lumen tunneled cvc and received numerous medications via a home health agency.The patient received regular tpn for short gut syndrome.Blood culture date (b)(6) 2018: positive for s.Marcescens.Administration dates for the following lot numbers are: lot #: 721481n, (b)(6) 2018: (b)(4) each, (b)(6) 2018: (b)(4) each, (b)(6) 2018: (b)(4) each, (b)(6) 2018: (b)(4) each, (b)(6) 2018: (b)(4) each.Lot #: 726571n, (b)(6) 2018: (b)(4) each, (b)(6) 2018: (b)(4) each.Mn plans to send some product from each of these lots to cdc for testing, except for heparin lot number 721481n (no remaining product), and this product was last administered on (b)(6) 2018.
Additional Manufacturer Narrative
Investigation summary: lot numbers 726571n and 721481n from product code 306521 were provided for evaluation by our quality engineer team.A device history record review did not reveal any deviations or non-conformances during the production of either lot number.A corrective and preventive action plan was initiated to further investigate and monitor this issue.One-hundred and twenty retained samples of each lot number were visually inspected and no abnormalities were observed regarding the solution.Forty retained samples for each lot number were sent for sterility testing.The sterility testing confirmed that the samples exhibited no microbial growth after incubation.A direct causation between the bd product and the reported infection has not been identified.Investigation conclusion: the root cause analysis of the reported infection case under capa (b)(4) has not identified a direct causation between the infections and the bd (b)(4) product.
Event or Problem Description
It was reported that a patient contacted a serratia marcescens after using a 3 ml bd posiflush¿ heparin lock flush syringe, in 10 ml syringe, 10 usp units/ml.The cdc indicated preliminary information from the mn public health lab shows the pfge of this isolate is a match to the outbreak strain.The cdc received this clinical isolate and plan on repeating the pfge as well.As of 5/1/2018 the following clinical information has been provided: - the patient has a double lumen tunneled cvc and received numerous medications via a home health agency.- the patient received regular tpn for short gut syndrome.- blood culture date (b)(6) 2018: positive for s.Marcescens.- administration dates for the following lot numbers are: lot #: 721481n (b)(6) 2018: 30 each (b)(6) 2018: 30 each (b)(6) 2018: 30 each (b)(6) 2018: 30 each (b)(6) 2018: 30 each lot #: 726571n (b)(6) 2018: 30 each (b)(6) 2018: 30 each mn plans to send some product from each of these lots to cdc for testing, except for heparin lot number 721481n (no remaining product), and this product was last administered on (b)(6) 2018.

• Brand Name: 3ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 10 USP UNITS/ML
• Common Device Name: PREFILLED HEPARIN FLUSH SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; 9630 south 54th street; franklin WI 53132
• MDR Report Key: 7478304
• Report Number: 2134319-2018-00010
• Device Sequence Number: 13872538
• Product Code: FOZ
• UDI-Device Identifier: 30382903065210
• UDI-Public: 30382903065210
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K011967
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2018

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
• Operator of Device: Other
• Device Catalogue Number: 306521
• Device Lot Number: SEE H.10.
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 07/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 10 YR