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

Catalog Number 308341

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 11/09/2023

Event Type  malfunction  

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 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 Description

No additional informatin received.

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.

• Brand Name: CAP TIP SYR LL/LS STER LF BLACK 10/TRAY
• Type of Device: 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
• MDR Text Key: 330021584
• Report Number: 2618282-2023-00106
• Device Sequence Number: 1
• Product Code: KYW
• UDI-Device Identifier: 30382903083412
• UDI-Public: (01)30382903083412
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/07/2024

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: Health Professional
• Device Catalogue Number: 308341
• Device Lot Number: 2307934
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/08/2023
• Supplement Dates Manufacturer Received: 01/07/2024
• Supplement Dates FDA Received: 01/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1