MAUDE Adverse Event Report: B.BRAUN MELSUNGEN AG INTROCAN SAFETY; IV CANNULAE

Catalog Number 4251652-02

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved has not 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: ref # 4251652-02, lot # 15m19g8306, 1 item, reports clip did not deploy when removed needle from catheter.No injury.

Manufacturer Narrative

(b)(4).Device history record: reviewed the device history record and no abnormalities found during in process and final control inspection.Investigation results: received one used (contaminated with blood) cannula hub of introcan safety pur 20g, 1.1x25mm-us without packaging.The capillary hub and protective cap were not returned for evaluation.Visually inspected the returned sample and found that the safety clip was located in the middle of the cannula, not in an engaged position.The safety clip was not deformed.The returned sample was subjected to functional test by repositioning the clip and retesting with a new catheter hub (g20) 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.This indicates that there was no rough surface or dented mark along the cannula surface that will prevent the safety clip from engaging the cannula tip.Based upon the investigation results, no specific conclusion can be drawn as to the cause of the reported event.If additional pertinent becomes available, a follow up report will be submitted.

• Brand Name: INTROCAN SAFETY
• Type of Device: IV CANNULAE
• 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 ; carl-braun-strasse 1; melsungen, hessen 34212 ; GM 34212 ; 5661712769
• MDR Report Key: 5594124
• MDR Text Key: 43205209
• Report Number: 9610825-2016-00220
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/17/2016,04/08/2016

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: 11/01/2020
• Device Catalogue Number: 4251652-02
• Device Lot Number: 15M19G8306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2016
• Distributor Facility Aware Date: 04/08/2016
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2016
• Initial Date Manufacturer Received: 04/08/2016
• Initial Date FDA Received: 04/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1