MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG DISCOFIX; ACCESSORIES, CATHETER

Catalog Number 15898

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/18/2021

Event Type  Death  

Manufacturer Narrative

This report has been identified as b.Braun (b)(4).(b)(4) investigation of 2021-01-29: investigation report - discofix-3 white sterile (b)(4).Background: (b)(4) received a phone call from a police station concerning a request of investigation into discofix (article number : 15898).A member of business unit called back to the police the following day, and it turned out that the case was about disconnection of an extension tube from the three way stop-cock (discofix), accompanied by patient's loss, due, most likely, to massive blood loss, based on the explanation by the police.Date of occurrence is (b)(6).The hospital reported the case to the local police station because of the serious consequences.In (b)(6) the sample was handed over to (b)(4) sales rep.And it was presented to qa department.The sample was returned with a valve (q-syte, b.D.) connected to one of the female ports.Following requests were addressed by the police for investigation into the sample; does the sample meet the product specification? presence of damage does the sample function as required? other remarks (eg.Cautions in use of the device, etc.).Investigation: in response to the request of the police, (b)(4) asked (b)(4) to conduct the investigation for; visual observation, luer taper gauge test, and air-tightness / liquid tightness test.Please note: the investigation at (b)(4) site was also aligned with the headquarters in (b)(4).Result: visual observation (x20) f.Port1: observation of female port 1 revealed a crack, as is denoted in pic.3 by the yellow arrows.Pic.3: f.Port1, a crack is observed.F.Port2: observation of female port 2 revealed no abnormal findings.Pic.4: f.Port2.No cracks, and no other abnormalities.M.Port: observation of the male port revealed no abnormal findings.Pic.5: male port.No cracks, and no other abnormalities.Iso luer taper gauge test (taper gauge: 20594-1).Luer taper gauge test showed that the two female ports (f.Port1 and f.Port2) conform to the taper gauge.(pic.6 and 7, next gage).For test of the male port, the lock ring has to be removed.The test should be non-destructive, and was, therefore, avoided.F.Port1 : conformed pic.6: luer taper gauge test of f.Port1.F.Port2 : conformed pic.7: luer taper gauge test of f.Port2.Air-tightness / liquid tightness test.Referred to iso 8536-12:2007 /amd.1:2012(e).Air tightness test.Test method: sample was submerged in the water of temperature of 40¿ applied air pressure of 50kpa for 15 sec.Result: leakage was observed from f.Port1.Liquid tightness test : test method: primed the sample with water and applied pressure of 200kpa for 15 min.Result: leakage (bubbles) was observed from f.Port1 right after the pressurization.Pic.8: air-tightness test: bubble is observed.Pic.9: liquid-tightness test: water leakage is observed.Conclusion: the sample conforms to the specification.Crack was identified in the female luer where q-syte valve was connected at the time of receipt.Due to the crack, leakage was observed in both air and liquid-tightness test.Please note: the cause for cracks in the lli-cone could be high tensions in combination with disinfectants and / or certain drug ingredients (oil, alcohol, lipids etc.).Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.

Event Description

As reported by the user facility (translation of user facility information by (b)(6)): product detached.Complaint: the connection between the disco fix (part number 15898) and the extension tube of another company has been disconnected.The details are as follows: an elderly patient who had been hospitalized died on (b)(6) 2021 am.At that time, the extension tube connected to our three-way stopcock came off, and blood was flowing back into the extension tube connected to the venous indwelling needle.Therefore, the hospital contacted the police as an abnormal death and started an investigation.(from the above, it is not possible to determine where the connection was disconnected.) the actual product has an extension tube connected.Moreover, a little chemical solution remains.Currently kept by the (b)(6) police station as evidence.

• Brand Name: DISCOFIX
• Type of Device: ACCESSORIES, CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 11350506
• MDR Text Key: 232824944
• Report Number: 9610825-2021-00037
• Device Sequence Number: 1
• Product Code: KGZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 15898
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death