MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. CARESITE (LAD); CARESITE LUER ACCESS DEVICE

Catalog Number 415122

Device Problem Chemical Spillage (2894)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

As reported by the user facility: event #1: reports several incidents of leakage from the caresite connector.There were two occurrences of chemo leakage involved.Lot numbers involved: lot 0061377144, nfgl (b)(6) 2014, expiration: 05/31/2017.Lot 0061379926, mfg: 08/2014, expiration: 07/31/2017.

Manufacturer Narrative

(b)(4).Five used caresite valves, without packaging, were received for evaluation.On all five caresite valves, cracks were observed on the female luer lock threads of the top of the valve and extended down to the bottom of the luer threads.Review of the discrepancy management system database performed for the reported lot numbers did not reveal any abnormalities or nonconformances of this nature.The investigation into this reported event is ongoing.Following the receipt of additional information and/or completion of the investigation, a follow-up report will be filed.

• Brand Name: CARESITE (LAD)
• Type of Device: CARESITE LUER ACCESS DEVICE
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; allentown PA
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109 ; 6102660500
• MDR Report Key: 4236591
• MDR Text Key: 18729129
• Report Number: 2523676-2014-00383
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: 415122
• Device Lot Number: 0061377144
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/15/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1