MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE CATHETER TIP 50ML; SYRINGE, IRRIGATING (NON DENTAL)

Catalog Number	309620
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr (b)(4).Follow up as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of defect during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.
Event or Problem Description
No additional information received.
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.
Event or Problem Description
Material: 309620 batch#: unknown.It was reported by the customer that "the cap that comes on the syr is not a tight enough fit and we sometimes use these syr for chemotherapy drugs and we are afraid of leakage or squirting out of drug.We were using item r2000b for months and it wasn't a problem an all of a sudden the cap doesn't fit as if there was a change to the syr tip." "the cap that comes on the syr is not a tight enough fit and we sometimes use these syr for chemotherapy drugs and we are afraid of leakage or squirting out of drug.We were using item r2000b for months and it wasn't a problem an all of a sudden the cap doesn't fit as if there was a change to the syr tip.".
Additional Manufacturer Narrative
Becton dickinson and company's (bd) medication delivery solutions (mds) business unit will discontinue malfunction mdr reporting for certain device failures that have not caused or contributed to deaths or serious injuries in the past two years, and where the likelihood of a death or serious injury as a result of these malfunctions is remote.This decision follows fda guidelines (medical device reporting for manufacturers guidance for industry and food and drug administration staff issued nov 8, 2016, reference section 2.15).Bd notified fda of this decision on mar 3, 2025.Fda has reviewed and responded to bd¿s notification (reference fda document(b)(4)) on march 7, 2025.This documentation is available in bd document management system (sap) as (b)(4).This supplemental mdr is being filed to document that the below device failure will no longer be considered a reportable malfunction mdr for the product family below: product family: conventional syringe - 20-100ml.Device failure: cap / shield loose / off.
Event or Problem Description
No additional information.

• Brand Name: SYRINGE CATHETER TIP 50ML
• 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: 20630166
• Report Number: 1911916-2024-00795
• Device Sequence Number: 15489931
• Product Code: KYZ
• UDI-Device Identifier: 30382903096207
• UDI-Public: (01)30382903096207
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 03/20/2025

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: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 11/11/2024; Not provided
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 11/11/2024; 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown