MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE CATHETER TIP 2OZ; SYRINGE, IRRIGATING (NON DENTAL)

Catalog Number	309620
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material #: 309620.Batch#: 4080096.It was reported by customer that pharmacy noticed that a certain lot of the bd# 309653 did not have scale markings on them.As their supply chain team began inspecting this product number and lot across the division, they then noticed that bd# 309620 of a certain lot also did not have scale markings.Complaint received via email(s) attached.Pharmacy noticed that a certain lot of the bd# 309653 did not have scale markings on them.As their supply chain team began inspecting this product number and lot across the division, they then noticed that bd# 309620 of a certain lot also did not have scale markings.
Additional 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.
Additional Manufacturer Narrative
Pr (b)(4) follow up: a device history record review was completed by our quality engineer team for provided material number 309620 and lot number 4080096.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 or Problem Description
No additional information received.Material #: 309620; batch#: 4080096.It was reported by customer that pharmacy noticed that a certain lot of the bd# 309653 did not have scale markings on them.As their supply chain team began inspecting this product number and lot across the division, they then noticed that bd# 309620 of a certain lot also did not have scale markings.Verbatim: complaint received via email(s) attached.Pharmacy noticed that a certain lot of the bd# 309653 did not have scale markings on them.As their supply chain team began inspecting this product number and lot across the division, they then noticed that bd# 309620 of a certain lot also did not have scale markings.

• Brand Name: SYRINGE CATHETER TIP 2OZ
• Common Device Name: SYRINGE, IRRIGATING (NON DENTAL)
• 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: 19824711
• Report Number: 1911916-2024-00538
• Device Sequence Number: 21003679
• Product Code: KYZ
• UDI-Device Identifier: 30382903096207
• UDI-Public: (01)30382903096207
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• 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,Followup
• Report Date (Section B): 08/22/2024

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: Health Professional
• Device Catalogue Number: 309620
• Device Lot Number: 4080096
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown