MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%; PREFILLED SALINE SYRINGE

Catalog Number 306572

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

Patient Problems Memory Loss/Impairment (1958); Dizziness (2194); Shaking/Tremors (2515)

Event Date 02/16/2021

Event Type  Injury  

Manufacturer Narrative

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 bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was involved with a serious injury with the patient experiencing a reaction.An ambulance was called to the scene to "review" the patient, but it has not been specified whether the patient received medical intervention.The following information was provided by the initial reporter: nurse arrived to flush additional lumen on patient¿s picc line and change extension set.After flushing with nacl 0.9% the patient become light headed, dizzy and started to vomit.Patient lay down on the bed and continued to be alert.Observations taken: 35.5, rr 14, heart rate 54, appeared pale, reported to be cold.Patient then had a loss of memory regarding the incident.Nurse report patient did not lose conscience or appear vacant.Patient also began to shake.Patient infuses tpn 7/7 via picc line.Self-caring with infusions.Has reported there have been no issues when infusing his tpn via the dedicated lumen.No line lock used.Ambulance called to review patient.

Event Description

It was reported that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was involved with a serious injury with the patient experiencing a reaction.An ambulance was called to the scene to "review" the patient, but it has not been specified whether the patient received medical intervention.The following information was provided by the initial reporter: nurse arrived to flush additional lumen on patient¿s picc line and change extension set.After flushing with nacl 0.9% the patient become light headed, dizzy and started to vomit.Patient lay down on the bed and continued to be alert.Observations taken: 35.5, rr 14, heart rate 54, appeared pale, reported to be cold.Patient then had a loss of memory regarding the incident.Nurse report patient did not lose conscience or appear vacant.Patient also began to shake.Patient infuses tpn 7/7 via picc line.Self-caring with infusions.Has reported there have been no issues when infusing his tpn via the dedicated lumen.No line lock used.Ambulance called to review patient.

Manufacturer Narrative

H.6.Investigation: a device history record review was completed for provided lot number 0335954.The review did not reveal any detected abnormalities during the production process that could have directly contributed to this defect.The laboratory results for this lot were reviewed and all in-process and finished product inspections were found to be within specification.All of the control tests ensured that the product was fit for its intended use and that the product met the standard requirements prior to release.As samples were unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, there is no evidence that the posiflush syringe was responsible for the reported patient¿s reaction.

• Brand Name: BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: PREFILLED SALINE SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 11508292
• MDR Text Key: 241752286
• Report Number: 9616657-2021-00030
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

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: Lay User/Patient
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 306572
• Device Lot Number: 0335954
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/18/2021
• Initial Date FDA Received: 03/17/2021
• Supplement Dates Manufacturer Received: 03/23/2021
• Supplement Dates FDA Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other