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

Model Number N/A

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  

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): a nurse has been punctured with the bevel of the needle.The shield did not functioned correctly.

Manufacturer Narrative

(b)(4).The device is currently shipping from (b)(6) to bbm in (b)(4) for investigation.A follow-up report will be provided when the inspection results are available.

Manufacturer Narrative

(b)(4).We received a picture of a introcan safety pur 18g, 1.3x32mm-eu.The picture was visually checked.On the picture we see an introcan cannula; the safety clip is activated near the tip of the cannula.We received one used and intense contaminated (contaminated with coagulated blood) introcan safety pur 18g, 1.3x32mm-eu without original packaging (the received primary packaging is one of a competitors syringe; 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 (is not in end position on the needles sharp bevel).The clip is approximately 2 mm away from the needle tip.The safety clip is damaged respectively bent apart on the needle.Further on, the complete needle is slightly bent too and the tip of the needle is damaged/blunt.Regarding the damaged safety clip we did not carry out a function test (sliding the safety clip on the needle).Our understanding is that these damages were not at the sample in original condition, thus it is most likely a problem during application.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 sample upon received - received one used introcan safety without original packaging.- received one competitors(bd) primary packaging.- the safety clip for returned sample was not in engaged position.- safety clip deformation was observed.- protective cap and catheter hub was not returned for evaluation.Clip inspection - clip deformation on both long arm and short arm hook were observed.Cannula tip inspection - tip blunt (0.12mm) and tip bent (7.5 degree) towards bevel eye on complaint sample were observed.Test plan matrix for simulation sample 1.Collect 1pc introcan safety g18 and activate the safety clip to the tip of cannula.( clip engaged at the tip of cannula) 2.Place the sample on table and hit the clip at the hook area.Simulation result - clip deformation on both long arm and short arm hook were observed.- tip blunt and tip bent towards bevel eye on simulation sample were observed.Conclusion: severe clip deformation was observed on complaint sample.(similar observation was showed on simulation sample) tip blunt (0.12mm) and tip bent (7.5 degree) towards bevel eye on complaint sample were observed.(similar observation was showed on simulation sample) in production, assembly machine are equipped with vision system to check clip condition and blunt tip.This kind of clip deformation and blunt tip are able to reject by machine vision system.In process qc and final control inspections also conducted clip functional test and no clip failure was encountered.Based on simulation, it can be concluded that the damage which occurred on both the safety clip and the cannula tip can only happen when a high force is applied to the clip while the clip is engaged on the cannula tip.The returned sample was used sample and there was no catheter hub returned for further evaluation.Therefore, the complaint is not judgable.Justification: not judgable reviewed the device history record and there were no such defect encountered during final control inspection.

• 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: 4884780
• MDR Text Key: 6266112
• Report Number: 9610825-2015-00235
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K982805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/12/2015,06/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2018
• Device Model Number: N/A
• Device Catalogue Number: 4251687-01
• Device Lot Number: 3F25258231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/12/2015
• Distributor Facility Aware Date: 06/10/2015
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/12/2015
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 07/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2013
• 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