MAUDE Adverse Event Report: BECTON DICKINSON CAP TIP SYR LL/LS STER LF BLACK 10/TRAY; CONTAINER, LIQUID MEDICATION, GRADUATED

Catalog Number	308341
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Additional 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.Device problem code: a1205 - loose or intermittent connection patient problem code: f27 ¿ no patient involvement.
Event or Problem Description
Materials#: 308341 batch#: 2307934 it was reported by the customer that the caps falling off luer tips.Verbatim: rcc received a complaint via email.Email(s) attached.The customer complaint of caps falling off luer tips.Samples received from customer and from initial review the cap easily fall off compared to supplied acceptable unit.Just from feel on my inspection the rejected cap is softer in feel in compression of the product.Further investigation needed to determine the difference in this lot.Also, there is no more of this lot at our facility, but did receive multiple packs as part of the returned product 90 pcs out of 100.Open package was not returned with claim.Lot no: 2307934.
Event or Problem Description
No additional informatin received.
Additional Manufacturer Narrative
Investigation summary: ninety luer tip caps sealed and unused received by our quality team for investigation.The samples were submitted to inspection for visual characteristics (incomplete tip cap as a result of improperly filled cavities during molding (part of tip cap missing due to stripping from mold), trimming operations) and dimensional testing.No defects or issues observed.The packaging process was evaluated and there is no process step or malfunction that would cause the reported issue.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.The luer tip caps are placed in an upright position in the tray to avoid touching attachments designed to prevent finger contamination.
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: miscellaneous anesthesia.Device failure: cap / shield loose / off.
Event or Problem Description
No additional information.

• Brand Name: CAP TIP SYR LL/LS STER LF BLACK 10/TRAY
• Common Device Name: CONTAINER, LIQUID MEDICATION, GRADUATED
• 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 ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18290253
• Report Number: 2618282-2023-00106
• Device Sequence Number: 6264652
• Product Code: KYW
• UDI-Device Identifier: 30382903083412
• UDI-Public: (01)30382903083412
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/21/2025

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: 308341
• Device Lot Number: 2307934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 01/07/2024; Not provided
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 01/07/2024; 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown