MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN® SAFETY; I.V. SAFETY CATHETER

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Needle Stick/Puncture (2462)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We received one used and contaminated (contaminated with coagulated blood) introcan safety pur 20g, 1.1x32mm-eu without packaging (the batch is unknown; the used capillary was not handed over by the customer).The received sample was taken to a visual inspection (particularly with regard to the clip and the needle).In as-received condition the safety clip is not activated on the tip of the needle.The clip is approximately 6 mm away from the needle tip.Damages or other deviations were not detected at the clip respectively at the sample.The safety clip was taken to a function test (sliding the safety clip on the needle).It was easily possible to slide the safety clip on the needle respectively to fix the clip on the tip of the needle.The special feature of a self-activating safety clip that automatically covers the needles sharp bevel was given.The safety clip is in end position on the needle tip after function test.In dependence on the test plan the needle with the activated safety clip was pushed against a stretched rubber glove.The needle, respectively the safety clip, did not puncture the rubber glove.With regard to the as-received condition the root cause of incorrect position of the safety clip on the needle cannot be comprehended.Therefore an evaluation is not possible.We have informed our manufacturer accordingly.Preliminary investigation: received one used cannula of introcan safety without packaging.The safety clip was activated and engaged at the tip of cannula.Safety clip was not deformed.Capillary hub was not returned for evaluation.Sample evaluation: the returned sample was checked by repositioning the clip and retesting its function by using new catheter hub (g20) and placing it onto the cannula and then pulling it and found that the clip engaged properly onto the tip of the cannula.There was no abnormality found while pulling the catheter out from the cannula.The clip engaged properly onto the tip of the cannula.There was no rough surface/dented mark observed on cannula surface.Ipqc: clip function test specification: clip function test will be conducted by in process quality control personnel based on the test specification.Clip functional failure is not allowed.Final control: clip function test specification: clip function test also will be conducted by qm quality controller personnel at final control based on the test specification.Clip functional failure is not allowed.Conclusion: during clip functionality test with a new catheter, there was no defect/damage found on the clip after pulling it out from the cannula.Also, the clip engages properly onto the tip of the cannula.There was no clip deformation.There was no rough surface/dented mark observed on cannula surface.Ipqc and final control also conducted clip functional test.There was no catheter hub returned for the used sample.Therefore, the complaint is not judgeable justification: not judgeable.The batch record could not be reviewed since the lot number is not known.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): safety system don't protecting the end of the needle.Needlestick injury.

• Brand Name: INTROCAN® SAFETY
• Type of Device: I.V. SAFETY 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: ludwig schuetz ; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212 ; 5661712769
• MDR Report Key: 5492913
• MDR Text Key: 40327159
• Report Number: 9610825-2016-00087
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K982805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/10/2016,06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 4251644-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/10/2016
• Distributor Facility Aware Date: 03/04/2016
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2016
• Date Manufacturer Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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