MAUDE Adverse Event Report: BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS ACCESS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number EMC3293

Device Problems Disconnection (1171); Chemical Spillage (2894)

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

Event Date 07/08/2014

Event Type  malfunction  

Event Description

It was reported that a mirafilter administration set tubing disconnected from the drip chamber.This occurred during infusion of paclitaxel.After the disconnection, the drug solution dripped on the patient.There was no patient injury or medical intervention.No additional information is available.

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).It was reported that after the chemotherapy agent came in contact with the patient the affected area was rinsed with a decontamination washing of amuchina (sodium ipochloride).A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was received for evaluation.During visual inspection, the tubing was observed to be disconnected from the millipore filter.The reported problem was verified.The cause of the problem was due to a manufacturing issue.A capa has been opened for this issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ACCESS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS; route de chebbaou - 2021oued e; tunis ; TS
• Manufacturer (Section G): BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS; route de chebbaou - 2021oued e; tunis ; TS
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3973795
• MDR Text Key: 4629797
• Report Number: 1416980-2014-25124
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 07/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: EMC3293
• Device Lot Number: 14A30V092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TAXOL (PACLITAXEL)