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

Catalog Number 306546

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/08/2024

Event Type  malfunction  

Event Description

Material #:unknown batch#:unknown it was reported by customer that the pt returned posiflush had precipitation (moisture),cloudy and saline had fm not sure what it is.In addition had resistance when trying to administer.Verbatim: rcc received a complaint via phone.Pir attached.Productcomplaint-mds facility: (b)(6).Address: xxxxxxxxxxxxxxxxxxxxxxxxxxxx contact: 1.Xxxxxxxxxxxxxxx (pharmacists) xxxxxxxxxxxxxxxxxxxx email:(b)(6).2.Xxxxxxxxxxxxxxxxxx pharmacist xxxxxxxxxxxxx email: xxxxxxxxxxxxxxxxxxxxxxxxxxx patients: xxxxxxxxxxxxxxxxxx- xxxxxxxxxxxxx alt xxxxxxxxxxxxxxxxxxx (b)(6).Issue: pt returned posiflush had precipitation (moisture),cloudy and saline had fm not sure what it is.In addition had resistance when trying to administer.Pht advised to hold onto product for evaluation and called to report for customer.Ref: unknown lot: 30271571 pt harm: no sample is available task for sample return kit please resistance doe: (b)(6) 2024 and (b)(6) 2024 fm doe (b)(6) 2024 please include pharmacist on communication as well.

Manufacturer Narrative

(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.H3 other text : see h10 manufacture narrative.

• Brand Name: SYRINGE 10ML REG PR SALINE 10ML FILL
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MDS DCHU; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18958397
• MDR Text Key: 339326869
• Report Number: 9616657-2024-00011
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903065463
• UDI-Public: (01)30382903065463
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/18/2024

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: Lay User/Patient
• Device Catalogue Number: 306546
• Device Lot Number: 3271571
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1