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

Catalog Number UNKNOWN

Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)

Patient Problems No Consequences Or Impact To Patient (2199); Needle Stick/Puncture (2462)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved has been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

As reported by the user facility: customer stated, reference number and lot number were reported as unknown; however, reports it was a introcan safety 18 gauge, no other information about the device is known.Event: needle stick injury.Nurse started iv successfully.The nurse set the needle to the side in plastic package and during clean up was stuck in the palm of the hand.Clip was about 1/2 way down the needle not covering the end.Reports general blood work completed and patient was negative for tested diseases.

Manufacturer Narrative

(b)(4).Received one used (contaminated with blood) cannula hub of introcan safety without packaging.The capillary hub and protective cap were not returned for investigation.Visually inspected the returned sample and found that the safety clip was located at the middle of the cannula (not in engaged position).Dhr: device history record bb (b)(4) provided sales data related to the customer of the possible batches and the batches are as follows: (b)(4).These possible batches were reviewed and no abnormalities found during in process and final control inspection.Unable to review the machine process card as it is an unknown batch number.Received one used cannula introcan safety without packaging.The safety clip was not in engaged position and dislodged to the side of cannula.Safety clip was not deformed.Catheter 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 (g18) 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.Summary of root cause analysis: there was no rough surface/dented mark observed on cannula surface.There was no clip deformation.If the clip is dislodged from the cannula, the catheter hub is unable to be assembled onto the needle as the hub will crush and damage the clip.Moreover, the assembly machine is also equipped with a vision system which conducts 100% inspection on the clip condition, it is unlikely that the defect escape from process.Cause : cause could not be determine.There was no catheter hub returned for further evaluation.This complaint is conclude as non-judgeable.Multiple attempts to obtain the lot number and further information were not successful.If additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: INTROCAN SAFETY®
• Type of Device: I.V. SAFETY CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun str.1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: ludwig schuetz ; b. braun melsungen ag; carl-braun str. 1; melsungen, 34212 ; GM 34212 ; 661712769
• MDR Report Key: 5718579
• MDR Text Key: 47205999
• Report Number: 9610825-2016-00361
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/19/2016,05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/19/2016
• Distributor Facility Aware Date: 05/27/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2016
• Date Manufacturer Received: 05/27/2016
• 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