MAUDE Adverse Event Report: BECTON DICKINSON SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306547

Device Problem Crack (1135)

Patient Problem Exposure to Body Fluids (1745)

Event Date 01/31/2024

Event Type  malfunction  

Event Description

Material #: 306547 batch#: 3090897.It was reported by customer that during the process of accessing the hemodialysis catheter, using a bd posi flush 09% sodium chloride injection syringe lot 3090897, we check the tightness of the access and when the employee was irrigating, there was a crack in the syringe, causing blood splatter from this patient into the eye.No further information received.

Manufacturer Narrative

Pr (b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.H3 other text : see h10 manufacture narrative.

Manufacturer Narrative

(b)(4).Follow up.A device history record review was completed by our quality engineer team for provided material number 306547 and lot number 3090897.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.

Event Description

No additional information received.Material #: 306547.Batch#: 3090897.It was reported by customer that during the process of accessing the hemodialysis catheter, using a bd posi flush 09% sodium chloride injection syringe lot 3090897, we check the tightness of the access and when the employee was irrigating, there was a crack in the syringe, causing blood splatter from this patient into the eye.Verbatim: complaint received via email(s) attached.During the process of accessing the hemodialysis catheter, using a bd posiflush 09% sodium chloride injection syringe lot 3090897, we check the tightness of the access and when the employee was irrigating, there was a crack in the syringe, causing blood splatter from this patient into the eye rcc received a complaint via email.Email(s) attached.Durant la technique d'accéder le cathéter d'hémodialyse, en utilisant une seringue bd posiflush 0.9 % sodium chloride injection # lot 3090897, nous vérifions l'étanchéité de l'accès et quand l'employé à faire irrigation, il avait une crack dans la seringue donc à eu éclaboussure de sang de cette patiente dans l'oeil.

• Brand Name: SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL
• 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 (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18712214
• MDR Text Key: 336520826
• Report Number: 1911916-2024-00101
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K003553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/19/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 306547
• Device Lot Number: 3090897
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other