MAUDE Adverse Event Report: BECTON DICKINSON, S.A. CONNECTOR LUER LOCK C35J

Catalog Number 515204

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

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

Event Date 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the connector luer lock c35j experienced leakage from the injector and mating component.The following information was provided by the initial reporter: according to the customer's report, when the hcp disengaged the injector after transferring the fluid (saline), leakage from around the connection to the injector was observed.

Manufacturer Narrative

Corrections: the following information has been updated/corrected: b.5.Describe event or problem: it was reported that the connector luer lock c35j experienced leakage from the injector and mating component, and the device was damaged while still considered operable.H.3.Device returned to manuf: yes.H.3.Device eval by manufacturer? yes.H.6.Imdrf annex a grid: a041001, a0504.Investigation: h.6.Investigation summary: one sample received for investigation, upon observation of the spike set and infusion bag, we found no abnormalities such as damage or molding defects.However, a perforation is observed in the membrane of the luer lock connector of the tip set.A device history review for lot 2102261c did not reveal any annotations or non-conformances during the manufacturing process related to this issue.He lot number for the connector is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Based on the investigation results, possible root cause is due to excessive perforations in the membrane.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification all critical dimensions are within specification and there is no damage on the product as described in the package insert, after repeated or prolonged use of the injector and connector (lure lock), the membrane performance may gradually deteriorate and the chemical solution may leak.Complaints received for this device and the reported condition will continue to be tracked and trended.The information will be collected in trend reports and monitored on a monthly basis.Our sales team regularly reviews the data collected to identify emerging trends.H3 other text : see h10.

Event Description

It was reported that the connector luer lock c35j experienced leakage from the injector and mating component, and the device was damaged while still considered operable.The following information was provided by the initial reporter: according to the customer's report, when the hcp disengaged the injector after transferring the fluid (saline), leakage from around the connection to the injector was observed.

• Brand Name: CONNECTOR LUER LOCK C35J
• Type of Device: CONNECTOR
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 12388886
• MDR Text Key: 273152923
• Report Number: 3003152976-2021-00523
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515204
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Date Manufacturer Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1