MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 36 CM (14¿) APROX 4,6 ML, SET LINEAL PUR, C/PUNZÓN C/VÁLVULA, MICROCLAVE®, FILTR; STOPCOCK, I.V. SET

Catalog Number 034-H2782

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2019

Event Type  malfunction  

Manufacturer Narrative

The device will not return for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The lot number of the device that was in use is unknown.The customer identified two possible lot numbers (plots).The possible lot numbers are 4094384 (expiry date 05/01/2024 , mfr date 05/01/2019) and 4040743 (expiry date 04/01/2024, mfr date 4/01/2019).

Event Description

The event involved an extension set that during the middle of an infusion of paclitaxel a leak was noted.The extension set was replaced, and the treatment was completed.There was no adverse event, no harm reported, no delay in critical therapy and no medical intervention required.

Manufacturer Narrative

No product samples were returned for investigation, however, a series of photographs were received and evaluated.The photos show one used 034-h2782 set.The tubing appears to be separated from the distal end of the y-clave.Insufficient solvent is visible on the y-clave and the tubing.The device history review (dhr) for possible lot numbers 4094384 and 4040743 were reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.The reported complaint can be confirmed based on the photo provided.The probable cause is due to an error in the manual bonding process during manufacturing.

• Brand Name: 36 CM (14¿) APROX 4,6 ML, SET LINEAL PUR, C/PUNZÓN C/VÁLVULA, MICROCLAVE®, FILTR
• Type of Device: STOPCOCK, I.V. SET
• 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: 9503969
• MDR Text Key: 206572508
• Report Number: 9617594-2019-00429
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 034-H2782
• Device Lot Number: PLOTS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PACLITAXEL, MFR UNK