MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN® SAFETY; I.V. 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 08/20/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device was not returned for evaluation.Without the actual sample, a thorough investigation could not be performed.The batch manufacturing 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 product code 4252543-02 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 of immediately into an appropriate sharps container.If a sample and/or additional pertinent information become available, a follow up report will be submitted.Not returned to manufacturer.

Event Description

As reported by the user facility: customer reports, (b)(4) lot # 15c30g831g, 1 item occurred (b)(6) 2015.Reports " the nurse started the iv like normal.Pulled out the needle and laid it on the bed.Taped the iv and when she picked up the needle stuck herself because the safety tip device did not deploy to the end of the needle." customer did not save the sample customer stated that the event occurred on (b)(6) 2015; however, the complaint was received on 8/19/2015.

• Brand Name: INTROCAN® SAFETY
• Type of Device: I.V. SAFETY CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun str. 1; melsungen 34212
• Manufacturer Contact: ludwig schuetz ; carl-braun str. 1; melsungen 34212 ; 4956617127
• MDR Report Key: 5038203
• MDR Text Key: 24356744
• Report Number: 9610825-2015-00353
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Report Date: 08/27/2015,08/19/2015

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: No Information
• Device Expiration Date: 03/01/2020
• Device Catalogue Number: 4252543-02
• Device Lot Number: 15C30G8316
• 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: 08/27/2015
• Distributor Facility Aware Date: 08/19/2015
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1