MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CLAVE CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	11956
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer stated that a device is available for evaluation; it has not been received.
Event or Problem Description
This event is associated with user facility medwatch number mw5091784.The event involved a clave connector where the inside stopper remained depressed and resulted in a leak of chemotherapy, taxol, onto the patient's skin.The leak occurred on the top of the clave where it connects to the tubing.The patient was properly handled and skin washing occurred.
Additional Manufacturer Narrative
H10: one (1) new list# 11956, clave® connector, lot # 4410418 was received for testing on (b)(6)2020.The reported complaint of leakage was not confirmed or replicated on the returned new list# 11956 clave.The clave was leak tested and put through a multiple activation test and no leaks or stick downs were observed.The clave was found to meet product specifications.The used clave and mating devices were not returned for investigation.A dhr (device history review) lot# 4410418 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• Brand Name: CLAVE CONNECTOR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 9612085
• Report Number: 9617594-2020-00017
• Device Sequence Number: 19517547
• Product Code: FPA
• UDI-Device Identifier: 00887709042193
• UDI-Public: (01)00887709042193(17)241001(10)4410418
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K970855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2020

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 Expiration Date: 10/01/2024
• Device Catalogue Number: 11956
• Device Lot Number: 4410418
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TAXOL, MFR UNK