MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 5ML SALINE FILL CE; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306574

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

Patient Problem Anaphylactic Shock (1703)

Event Date 11/11/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if a device evaluation and/or device history review is completed.Device problem code: a24 - adverse event without identified device or use problem patient problem code: f08 - hospitalization or prolonged hospitalization.E040201 - anaphylactic shock.

Event Description

Customer states " had 3 anaphylactic reactions after handing and being given posiflush".On 14 nov 2023 additional information: a nurse from (b)(6) hospital emergency advising she¿s had an anaphylactic reaction following being exposed to posiflush on last saturday.The customer states ¿ i used the posiflush on a patient and afterwards i had itchy hands, then a full anaphylactic reaction.I was administered im adrenaline afterwards and was admitted to icu¿.She did also state that she had handled an antibiotic prior to this.

Manufacturer Narrative

(b)(4).Follow up.As no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of defect during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.

Event Description

(b)(4).No additional information received.Customer states "had 3 anaphylactic reactions after handing and being given posiflush".On 14 nov 2023, additional information: a nurse from caboollture hospital emergency advising she¿s had an anaphylactic reaction following being exposed to posiflush on last saturday.The customer states ¿ i used the posiflush on a patient and afterwards i had itchy hands, then a full anaphylactic reaction.I was administered im adrenaline afterwards and was admitted to icu¿.She did also state that she had handled an antibiotic prior to this.

• Brand Name: SYRINGE 5ML SALINE FILL CE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18290254
• MDR Text Key: 330001387
• Report Number: 1911916-2023-00879
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065745
• UDI-Public: (01)00382903065745
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 306574
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female