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

Catalog Number 306572

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

Patient Problem Numbness (2415)

Event Date 12/02/2022

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 after use of the bd posiflush¿ pre-filled saline syringe, the patient developed slurred speech, numbness to the right side of her face and weakened right arm.Symptoms spontaneously resolving after a minute or so.The following information was provided by the initial reporter: the customer states that immediately after flushing her daughter¿s picc line, she developed slurred speech, numbness to the right side of her face and weakened right arm.Symptoms spontaneously resolving after a minute or so.The customer has provided the following further information for this adverse event: ¿the posiflush was used to flush the patients picc line just prior to connecting her tpn as per protocol.There was no damaging to the packaging at all.I visibly checked the syringe and it was in date, labelled correctly and with no obvious damage.To my knowledge to date the patient has not experienced this when using other syringes from the same lot, either prior to this incident or since this incident.¿.

Event Description

It was reported that after use of the bd posiflush¿ pre-filled saline syringe, the patient developed slurred speech, numbness to the right side of her face and weakened right arm.Symptoms spontaneously resolving after a minute or so.The following information was provided by the initial reporter: the customer states that immediately after flushing her daughter¿s picc line, she developed slurred speech, numbness to the right side of her face and weakened right arm.Symptoms spontaneously resolving after a minute or so.The customer has provided the following further information for this adverse event: ¿the posiflush was used to flush the patients picc line just prior to connecting her tpn as per protocol.There was no damaging to the packaging at all.I visibly checked the syringe and it was in date, labelled correctly and with no obvious damage.To my knowledge to date the patient has not experienced this when using other syringes from the same lot, either prior to this incident or since this incident.¿.

Manufacturer Narrative

H6: investigation summary a device history record review was completed for provided material number (b)(4) and lot number 2166764.The review did not reveal any possible non-conformances that could have contributed to this reported incident.All relevant in-process and finished product inspections found that the product was fit for its intended use and met all standard requirements.As samples were unavailable for return, a thorough sample analysis could not be performed.As per specifications, the composition of this product is sodium chloride dissolved in water for injection, to produce a 0.9% sodium chloride solution.In addition, this product is not made with natural rubber latex or preservatives.This product is also non-toxic and non-pyrogenic.At this time, a cause could not be identified for this reported event.H3 other text : see h10.

• Brand Name: BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16585582
• MDR Text Key: 311740581
• Report Number: 9616657-2023-00007
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/27/2023

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: 306572
• Device Lot Number: 2166764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 03/27/2023
• Supplement Dates FDA Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• 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): Other