MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD PREFILLED SALINE SYRINGE; SALINE, VACULAR ACCESS FLUSH

Catalog Number UNKNOWN

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 09/21/2022

Event Type  Injury  

Event Description

It was reported that the unspecified bd prefilled saline syringe was involved with an adverse event, without an identified device malfunction/defect.The patient reported experiencing a severe reaction, including low blood pressure, lipothymia, closed throat, and convulsive movements.The following information was provided by the initial reporter: i still react very poorly to the product, which is a very common product that is used in many different situations, and therefore easy to miss when i am admitted in the hospital.I know i can¿t be allergic to nacl, but it must be something else.My reactions are as follows: * low blood pressure and lipotymia.* turns the eyes back in the head so only the white shows.* alienation of the body ¿ feeling.* all my joints and muscles stretch out, so i can¿t bend anything, but just lie like a stiff board.* red rash on the arm that has been injected.* my throat closes up.* convulsive movements.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the unspecified bd prefilled saline syringe was involved with an adverse event, without an identified device malfunction/defect.The patient reported experiencing a severe reaction, including low blood pressure, lipothymia, closed throat, and convulsive movements.The following information was provided by the initial reporter: i still react very poorly to the product, which is a very common product that is used in many different situations, and therefore easy to miss when i am admitted in the hospital.I know i can¿t be allergic to nacl, but it must be something else.My reactions are as follows: low blood pressure and lipotymia.Turns the eyes back in the head so only the white shows.Alienation of the body ¿ feeling.All my joints and muscles stretch out, so i can¿t bend anything, but just lie like a stiff board.Red rash on the arm that has been injected.My throat closes up.Convulsive movements.

Manufacturer Narrative

H6: investigation summary.Per the provided feedback, we understand that this issue is not specific to a material number, lot number, or a sample; however, without such specifications, our investigative engineer team was unable to identify any potential manufacturing related causes for the reported reaction.Our investigative team is unable to relay the details of product composition.A device history review could not be completed as no batch number was provided.

• Brand Name: UNSPECIFIED BD PREFILLED SALINE SYRINGE
• Type of Device: SALINE, VACULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15615898
• MDR Text Key: 301842643
• Report Number: 2243072-2022-01769
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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