MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE; PISTON SYRINGE

Catalog Number	303134
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd syringe barrel/flange was damaged.The following information was provided by the initial reporter: "we ordered a bd syringe though medline that we believe falls under this issue.We have a verge reports on the device breaking and spraying blood during a draw.I have included the bd also if they would do the qa vs.Medline." additional information received on 01/08/2024: 1.Any adverse event or serious injury reported to patient or healthcare professional? no.2.Was there a delay of, or change in, the course of treatment due to the event? yes.3.Any sample or photo available for investigation? no.4.How was the patient outcome? are there any clinical signs, health consequences or impact? no.5.How was treatment completed for customer? grabbed another syringe.6.Patient status?n/a.7.Any picture of this complaint no.8.Please explain elaborate issue? when using a 10 ml slip tip bd syringe to draw a blood sample from iv start, there was a hole in the syringe chamber straight from package.This was not noticed until blood starting coming from the hole.9.Date of event? 12/15.2023.10.Physical available/not available? no.12.Customer address? (b)(6).13.This material number is correct or not? correct.14.Please provide correct batch number? c-198 8.

• Brand Name: BD SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18522489
• Report Number: 1213809-2024-00005
• Device Sequence Number: 3665975
• Product Code: FMF
• UDI-Device Identifier: 00382903031344
• UDI-Public: (01)00382903031344
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2024

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
• Operator of Device: Other
• Device Catalogue Number: 303134
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown