MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 10ML SALINE FILL CAN SP; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306592

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/02/2024

Event Type  malfunction  

Manufacturer Narrative

Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

Material: unknown batch#: 3324220.It was reported by the customer that prefilled saline syringe is leaking out the inner plunger.Verbatim: hello, we have received the below product problem report.(b)(6) ref# (b)(4) has been assigned to this issue.Upon completion, please provide a quality investigation letter detailing your findings.Please advise on next steps for quality investigation and customer resolution: product problem report product information product code: 306592 product description: syringe sp posiflush 10ml saline fill bx/30 p20 lot/serial #: (b)(6) expiry date: 2026-11-30.Problem information prefilled saline syringe is leaking out the inner plunger occurrences: 1 each.Sample information incident samples: 1 each representative samples: 0.No adverse event reported.

Event Description

Additional information received 1.Kindly provide the date of event.¿(b)(6) 2024 2.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.¿could potentially leak back any blood in the syringe system and creates a hazard for both nurse and patient for blood and body fluid exposure¿ material: 306592 batch#: 3324220 it was reported by the customer that prefilled saline syringe is leaking out the inner plunger.Verbatim: hello, we have received the below product problem report.Stevens ref#(b)(4) has been assigned to this issue.Upon completion, please provide a quality investigation letter detailing your findings.Please advise on next steps for quality investigation and customer resolution: ________________________________________ product problem report product information product code: 306592 product description: syringe sp posiflush 10ml saline fill bx/30 p20 lot/serial #: (b)(6) expiry date: 2026-11-30 problem information prefilled saline syringe is leaking out the inner plunger occurrences: 1 each reporter information reporter name: xxxx reporter position/department: xxxx reporter phone: xxxx reporter email: xxx site information xxxxxx sample information incident samples: 1 each representative samples: 0 no adverse event reported.

Manufacturer Narrative

(b)(4) follow up a device history record review was completed by our quality engineer team for provided material number 306592 and lot number 3324220.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.H3 other text : see h10 narrative.

• Brand Name: SYRINGE 10ML SALINE FILL CAN SP
• 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: 19106065
• MDR Text Key: 340907433
• Report Number: 1911916-2024-00259
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K161552
• 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: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 306592
• Device Lot Number: 3324220
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 05/06/2024
• 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