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

Catalog Number 4251687-02

Device Problem Break (1069)

Patient Problems Needle Stick/Puncture (2462); Device Embedded In Tissue or Plaque (3165)

Event Date 10/05/2016

Event Type  Injury  

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: "started iv, grenn hub disconnected from the catheter.Iv started successfully, catheter hub disconnected from the catheter.Iv catheter was left inside the patients right forearm.Pressure was applied to the site, patient went to o.R.For a surgeon to attempt to remove it." sample available.

Manufacturer Narrative

(b)(4).Received 1 used (contaminated with blood) capillary and cannula hub of introcan safety pur 18g, 1.3x32 mm-us in opened packaging and 53 pieces introcan safety pur 18g, 1.3x32 mm-us in original packaging.No abnormalities found on the cannula.No abnormalities found on the 53 pieces of introcan safety pur 18g in original packaging.Observed that the capillary length that still intact with the housing is approximately 0.7 mm.Approximately 31.3 mm length has been broken off.The remaining capillary of around 31.3 mm is not returned for investigation.The crack surface on capillary is not able to be reproduced in the manufacturing process and any broken off capillary can be detected by the in-line vision system in the manufacturing process.Simulation at capillary cutting station: the simulation shows that the cutting station will not cause such defect as the complaint sample because the capillary after cutting is a clean cut surface which is not similar to the complaint sample.The capillary of the simulation sample after cutting process is approximately 5 mm (originally 37 mm) from the tip compare to the complaint sample which has been cut off approximately 31.3 mm from the tip which was not possible to be caused by the machine.If additional pertinent information becomes available, a follow up report 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 (Section G): 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: 6042371
• MDR Text Key: 57916365
• Report Number: 9610825-2016-00660
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2016,10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Catalogue Number: 4251687-02
• Device Lot Number: 16D05G8392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2016
• Distributor Facility Aware Date: 10/05/2016
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2016
• Date Manufacturer Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/05/2016
• 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): Other
• Patient Age: 82 YR
• Patient Weight: 97