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

Model Number B3300

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation.It is yet to be received.

Event Description

The customer reported a microclave neutral connector that leaked roughly 50-75mls of blood on a patient with low platelets.The event was discovered during a routine hourly access check.Intravenous fluids were reported as being used.The medical team ordered antibiotics.The set up was a huber needle to clave.There was patient involvement, but no adverse event, or human harm reported.

Manufacturer Narrative

H10: one (1) used list# b3300, clave¿ neutral connector.Lot# unknown, one (1) used spinning spiros, unknown list#, unknown lot#, one (1) extension set, unknown manufacturer along with one (1) safestep huber needle set, lot number ascv0202, ref 0724134.Manufacturer bard were received on august 31, 2020 for evaluation.The b3300 clave neutral connector was pressure leak tested as returned with the bard safestep huber needle set as described in the complaint and there was no leakage or propensity to disconnect observed during testing.The luers of the b3300 clave neutral connector and bard safestep huber needle set were both measured and both were found to be iso compatible.The complaint of leakage was unable to be replicated or confirmed.A device history review lot review could not be conducted because no lot number(s) was/were identified.

• Brand Name: MICROCLAVE NEUTRAL CONNECTOR
• Type of Device: 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: 10527966
• MDR Text Key: 206774766
• Report Number: 9617594-2020-00387
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K100434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B3300
• Device Catalogue Number: B3300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SAFESTEP HUBER NEEDLE; UNSP IV FLUIDS, MFG UNK; SAFESTEP HUBER NEEDLE; UNSP IV FLUIDS, MFG UNK