MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 3 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 3 ML SYRINGE; PREFILLED SALINE FLUSH SYRINGE

Catalog Number	306507
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	04/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Multiple potential lot numbers were provided for this incident.The information for each potential lot number is as follows: lot #: exp.Date: mfg.Date: 705311b, 2/21/2020, 2/22/2017.705312b, 2/21/2020, 2/22/2017.705411b, 2/22/2020, 2/23/2017.705411c, 2/22/2020, 2/23/2017.705412b, 2/22/2020, 2/23/2017.705511b, 2/23/2020, 2/24/2017.705512b, 2/23/2020, 2/24/2017.705811b, 2/26/2020, 2/27/2017.705812b, 2/26/2020, 2/27/2017.705911b, 2/27/2020, 2/28/2017.705912b, 2/27/2020, 2/28/2017.706011b, 2/29/2020, 2/28/2017.706111b, 3/1/2020, 3/2/2017.706112b, 3/1/2020, 3/2/2017.706212b, 3/2/2020, 3/3/2017.706511b, 3/5/2020, 3/6/2017.706612b, 3/6/2020, 3/7/2017.706711b, 3/7/2020, 3/8/2017.706712b, 3/7/2020, 3/8/2017.706811b, 3/8/2020, 3/9/2017.706812b, 3/8/2020, 3/9/2017.706911b, 3/9/2020, 3/10/2017.707212b, 3/12/2020, 3/13/2017.707311b, 3/13/2020, 3/14/2017.707411b, 3/14/2020, 3/15/2017.710012c, 4/9/2020, 4/10/2017.710111c, 4/10/2020, 4/11/2017.710211c, 4/11/2020, 4/12/2017.710713c, 4/16/2020, 4/17/2017.710911c, 4/18/2020, 4/19/2017.710912c, 4/18/2020, 4/19/2017.711011c, 4/19/2020, 4/20/2017.711012c, 4/19/2020, 4/20/2017.711111c, 4/20/2020, 4/21/2017.711112c, 4/20/2020, 4/21/2017.711412c, 4/23/2020, 4/24/2017.711511c, 4/24/2020, 4/25/2017.711512c, 4/24/2020, 4/25/2017.711612c, 4/25/2020, 4/26/2017.711711c, 4/26/2020, 4/27/2017.711712c, 4/26/2020, 4/27/2017.711811c, 4/27/2020, 4/28/2017.713111c, 5/10/2020, 5/11/2017.713212c, 5/11/2020, 5/12/2017.713512c, 5/14/2020, 5/15/2017.713612c, 5/15/2020, 5/16/2017.713711c, 5/16/2020, 5/17/2017.713811c, 5/17/2020, 5/18/2017.713912c, 5/18/2020, 5/19/2017.714211c, 5/21/2020, 5/22/2017.714311c, 5/22/2020, 5/23/2017.715012c, 5/29/2020, 5/30/2017.715211c, 5/31/2020, 6/1/2017.715311c, 6/1/2020, 6/2/2017.715611b, 6/4/2020, 6/5/2017.715711b, 6/5/2020, 6/6/2017.715811b, 6/6/2020, 6/7/2017.715911b, 6/7/2020, 6/8/2017.716011b, 6/8/2020, 6/9/2017.716111b, 6/9/2020, 6/10/2017.716311b, 6/11/2020, 6/12/2017.716411b, 6/12/2020, 6/13/2017.718811c, 7/6/2020, 7/7/2017.719111c, 7/9/2020, 7/10/2017.719211c, 7/10/2020, 7/11/2017.719311c, 7/11/2020, 7/12/2017.719411c, 7/12/2020, 7/13/2017.719511c, 7/13/2020, 7/14/2017.719812c, 7/16/2020, 7/17/2017.719912c, 7/17/2020, 7/18/2017.720011c, 7/18/2020, 7/19/2017.720111c, 7/19/2020, 7/20/2017.720211c, 7/20/2020, 7/21/2017.720511c, 7/23/2020, 7/24/2017.722612b, 8/13/2020, 8/14/2017.722711b, 8/14/2020, 8/15/2017.722811b, 8/15/2020, 8/16/2017.722911b, 8/16/2020, 8/17/2017.723011b, 8/17/2020, 8/18/2017.723311b, 8/20/2020, 8/21/2017.723512b, 8/22/2020, 8/23/2017.723611b, 8/23/2020, 8/24/2017.723612b, 8/23/2020, 8/24/2017.723711b, 8/24/2020, 8/25/2017.723712b, 8/24/2020, 8/25/2017.723811b, 8/25/2020, 8/26/2017.723812b, 8/25/2020, 8/26/2017.724011b, 8/27/2020, 8/28/2017.724012b, 8/27/2020, 8/28/2017.724111b, 8/28/2020, 8/29/2017.724112b, 8/28/2020, 8/29/2017.724211b, 8/29/2020, 8/30/2017.724212b, 8/29/2020, 8/30/2017.724311b, 8/30/2020, 8/31/2017.724312b, 8/30/2020, 8/31/2017.724411b, 8/31/2020, 9/1/2017.724812b, 9/4/2020, 9/5/2017.724911b, 9/5/2020, 9/6/2017.725011b, 9/6/2020, 9/7/2017.725111b, 9/7/2020, 9/8/2017.725211b, 9/8/2020, 9/9/2017.725411b, 9/10/2020, 9/11/2017.725611c, 9/12/2020, 9/13/2017.725711c, 9/13/2020, 9/14/2017.725811c, 9/14/2020, 9/15/2017.728512c, 10/11/2020, 10/12/2017.728611c, 10/12/2020, 10/13/2017.729012c, 10/16/2020, 10/17/2017.729111c, 10/17/2020, 10/18/2017.729211c, 10/18/2020, 10/19/2017.729311c, 10/19/2020, 10/20/2017.729711c, 10/23/2020, 10/24/2017.729712c, 10/23/2020, 10/24/2017.729811c, 10/24/2020, 10/25/2017.729812c, 10/24/2020, 10/25/2017.729911c, 10/25/2020, 10/26/2017.729912c, 10/25/2020, 10/26/2017.730011c, 10/26/2020, 10/27/2017.730012c, 10/26/2020, 10/27/2017.730111c, 10/27/2020, 10/28/2017.731011c, 11/5/2020, 11/6/2017.731012c, 11/5/2020, 11/6/2017.731112c, 11/6/2020, 11/7/2017.731211c, 11/7/2020, 11/8/2017.731212c, 11/7/2020, 11/8/2017.731311c, 11/8/2020, 11/9/2017.731312c, 11/8/2020, 11/9/2017.731411c, 11/9/2020, 11/10/2017.731712c, 11/12/2020, 11/13/2017.731812c, 11/13/2020, 11/14/2017.731911c, 11/14/2020, 11/15/2017.732011c, 11/15/2020, 11/16/2017.732111c, 11/16/2020, 11/17/2017.732411c, 11/19/2020, 11/20/2017.732511c, 11/20/2020, 11/21/2017.733511c, 11/30/2020, 12/1/2017.733811c, 12/3/2020, 12/4/2017.733911c, 12/4/2020, 12/5/2017.734011c, 12/5/2020, 12/6/2017.734012c, 12/5/2020, 12/6/2017.734111c, 12/6/2020, 12/7/2017.734512c, 12/10/2020, 12/11/2017.734611c, 12/11/2020, 12/12/2017.734711c, 12/12/2020, 12/13/2017.734811c, 12/13/2020, 12/14/2017.734911c, 12/14/2020, 12/15/2017.735011c, 12/15/2020, 12/15/2017.735211c, 12/17/2020, 12/15/2017.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 an infant in an nicu tested positive for s.Marcescens while using a 3 ml bd¿ pre-filled normal saline syringe, in 3 ml syringe.It is unknown what specific medical interventions may have been provided.It was also confirmed that the infant is recovering nicely.
Additional Manufacturer Narrative
H.6.Investigation summary: upon review of all 148 potential lot numbers provided, there were no manufacturing related issues noted during the production of the potential lots listed in the complaint file that may have contributed to the reported issue.All product specifications and lot release acceptance criteria for the potential lots listed were met.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.Capa 350041 was initiated to address this issue.Although retain samples are available for all lots manufactured in franklin, as the lot number was not provided, retain samples were not tested.Samples and/or pictures were not provided for evaluation.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.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 or Problem Description
It was reported that an infant in an nicu tested positive for s.Marcescens while using a 3 ml bd¿ pre-filled normal saline syringe, in 3 ml syringe.It is unknown what specific medical interventions may have been provided.It was also confirmed that the infant is recovering nicely.

• Brand Name: 3 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 3 ML SYRINGE
• Common Device Name: PREFILLED SALINE FLUSH SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; 9630 south 54th street; franklin WI 53132
• MDR Report Key: 7478708
• Report Number: 2134319-2018-00012
• Device Sequence Number: 1339673
• Product Code: FOZ
• UDI-Device Identifier: 30382903065074
• UDI-Public: 30382903065074
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K011982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2018

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: 306507
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 04/24/2018
• 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: Other