MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.36 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE, CLAMPS, ROTAT; STOPCOCK, I.V. SET

Model Number B3316

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Death (1802); Sepsis (2067)

Event Date 05/01/2020

Event Type  Death  

Manufacturer Narrative

The device is available for investigation.It has not been received.

Event Description

The event involved a 7" (18 cm) appx 0.36 ml, smallbore bifuse ext set w/2 microclave¿, clamps, rotating luer.The customer reported one of the hubs had a tear in the rubber part causing a huge leak with blood back up on a micropremie and they needed to pull the picc.The customer reported the patient ended up septic (unknown if associated) and did die (again inconclusive that they are related)".The customer reported there was an adverse event, the patient was harmed as a result of the reported event, and there was a delay in critical therapy.Although the customer was asked, the date of the patient's death was not provided.No additional information was provided.

Manufacturer Narrative

H10: no product samples were returned for investigation, however, a photograph was provided and evaluated.The photo shows two microclaves from a b3316, bifuse extension set.An arrow is pointing at the top of the seal on one of the claves that appears to have a tear that extends from the area of the slit to the outer rim of the seal.No other visible damage or anomalies can be seen.A device history review (dhr) lot review could not be conducted because no lot number(s) was/were identified.Follow up attempts were made with the customer to obtain information on available sister samples, the lot number, and mating devices used.No additional information was received.The reported complaint of a tear in the seal can be confirmed based on the photograph provided.However, without the return of a sample or mating device, a probable cause cannot be determined.

• Brand Name: 7" (18 CM) APPX 0.36 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE, CLAMPS, ROTAT
• 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: 10133544
• MDR Text Key: 194494073
• Report Number: 9617594-2020-00167
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B3316
• Device Catalogue Number: B3316
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death