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

Catalog Number 4252543-02

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 Date 11/08/2014

Event Type  malfunction  

Event Description

As reported by the user facility through medwatch report: "event desc: rn successfully started an iv then pushed the needle cover to secure device.When the used supplies were being picked up the nurse was stuck by the used needle.Upon inspection it appeared that the needle cover malfunctioned and didn't cover the sharp.No harm to the pt.Nurse was exposed to pt's blood/body fluids via unintentional needle stick.(b)(4).

Manufacturer Narrative

(b)(4).The actual device was not returned for eval.Without the actual sample, a thorough investigation could not be performed.The batch mfg record was reviewed and there were no such defect encountered during in-process inspection and at final control inspection.The process cards showed no abnormalities.A historical review of the complaint database identified no adverse trends for prod code 4552543-02 or the involved lot.Per the event description, it was reported that "when the used supplies were being picked up the nurse was stuck by the used needle".It should be noted that the introcan safety is designed to reduce the risk of needle stick injuries.However, cdc guidelines and/or facility protocols should always be followed.Sharps should be disposed if immediately into an appropriate sharps container.If a sample and/or add'l pertinent info become available, a f/u report will be submitted.

• Brand Name: INTROCAN SAFETY
• Type of Device: IV SAFETY CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str.1; melsungen, hessen 3421 2; GM 34212
• Manufacturer Contact: ludwig schuetz ; carl-braun-str.1; melsungen, hessen 34212 ; GM 34212 ; 661712769
• MDR Report Key: 4810520
• MDR Text Key: 21833469
• Report Number: 9610825-2015-00202
• Device Sequence Number: 1
• Product Code: FOZ
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/27/2015,05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/01/2019
• Device Catalogue Number: 4252543-02
• Device Lot Number: 14F26G8304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/27/2015
• Distributor Facility Aware Date: 05/14/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2015
• Date Manufacturer Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/26/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1