MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE; PREFILLED SALINE SYRINGE

Catalog Number 306582

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sepsis (2067)

Event Date 11/25/2022

Event Type  Death  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 1196818.Medical device expiration date: 30-jun-2024.Device manufacture date: (b)(6) 2021.Medical device lot #: 1251978.Medical device expiration date: 31-aug-2024.Device manufacture date: (b)(6) 2021.

Event Description

It was reported that there was a death while using bd posiflush¿ pre-filled saline syringe.The following information was provided by the initial reporter: patient died due to sepsis which initiate an environmental screening for the patient care setting including posiflush.Patient died due to sepsis which initiate a complete environmental screening for setting for the units including the prefilled syringes (posiflush 10 ml xs.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 01-dec-2022.H6: investigation summary: to aid in the investigation of this issue, six (6) 10ml syringes and six (6) 5ml syringes were returned for evaluation by our quality engineer team.All of the twelve (12) syringes were received in their original, unopened blister packaging.However, only four (4) of the syringes belonged to the lot numbers reported in this event.Unfortunately, testing was not conducted on the returned samples, as they were not controlled/handled appropriately during the shipment return process.The returned samples were loose within a courier bag outside of their original secondary packaging (shelf carton), so it could not be determined if the sterility barrier of the package had been breached or damaged in transit.A device history record review was completed for provided material number 306582 and batch numbers 1196818 and 1251978.The review did not reveal any non-conformances during the production process that could have contributed to the reported incident.

Event Description

It was reported that there was a death while using bd posiflush¿ pre-filled saline syringe.The following information was provided by the initial reporter: patient died due to sepsis which initiate an environmental screening for the patient care setting including posiflush.Patient died due to sepsis which initiate a complete environmental screening for setting for the units including the prefilled syringes (posiflush 10 ml xs).

• Brand Name: BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE
• Type of Device: PREFILLED SALINE SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15991944
• MDR Text Key: 305580664
• Report Number: 9616657-2022-00048
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2023

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
• Device Operator: Other
• Device Catalogue Number: 306582
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 02/01/2023
• Supplement Dates FDA Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death