MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC IV MONITORING KIT, DISPOSABLE TRANSDUCER, 03 ML SQUEEZE FLUSH, MACRODR; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 01C-42584-05

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not been received.

Event Description

The event involved a transpac iv monitoring kit that was reported to separate near the stopcock.The event occurred during priming.The type of procedure was bp monitoring and no medication was involved.The device was replaced with no further problems encountered.There was patient involvement, however there was no blood loss, no adverse event or patient harm, no delay in critical therapy and no medical intervention was required.The status of the patient was returned to baseline condition.

Manufacturer Narrative

D10 - date returned to mfg - august 24, 2020.One list# 01c-42584-05, transpac® iv monitoring kit, disposable transducer, 03 ml squeeze flush, macrodrip.Lot# 4774944 was received for evaluation.The reported complaint of line separation was confirmed on the returned set.During visual inspection the 48" pressure tubing was found separated from the winged male luer.The end of the pressure tubing was found tacky and the presence of uv adhesive was observed.The probable cause of the tubing separation was the uv adhesive not being fully cured during the manufacturing process.A representative pull test was conducted and the tubing broke near the male luer within the specifications.A device history review for lot# 4774944 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• Brand Name: TRANSPAC IV MONITORING KIT, DISPOSABLE TRANSDUCER, 03 ML SQUEEZE FLUSH, MACRODR
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• 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: 10352223
• MDR Text Key: 203491844
• Report Number: 9617594-2020-00278
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619035730
• UDI-Public: (01)00840619035730(17)230301(10)4774944
• Combination Product (y/n): N
• PMA/PMN Number: K061573
• 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: 07/14/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Catalogue Number: 01C-42584-05
• Device Lot Number: 4774944
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: 09/21/2020
• Supplement Dates FDA Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1