MAUDE Adverse Event Report: AMEDA INC. HYGIENIKIT; PUMP, BREAST, NON-POWERED

Catalog Number 17152

Device Problem Suction Problem (2170)

Patient Problem Laceration(s) (1946)

Event Date 08/05/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, an ameda sales representative, working with (b)(4), sent an email to inform ameda that one week prior, an inpatient was cut while using dual hygienikit breast flanges while pumping with the multi-user platinum pump.Per the sales representative, the patient was not fitted for proper flange size until after the injury.At the time, the patient reported "rubbing while pumping".The hospital declined to release patient information due to hippa regulations.

Manufacturer Narrative

The ameda sales representative met with the hospital nurse manager on (b)(6) 2014 and reviewed the importance of proper breast flange fit.The representative gave the hospital new platinum quick cards with breast flange fit guidelines.

• Brand Name: HYGIENIKIT
• Type of Device: PUMP, BREAST, NON-POWERED
• Manufacturer (Section D): AMEDA INC.; buffalo grove IL
• Manufacturer Contact: 485 e half day rd ste 320; buffalo grove, IL 60089 ; 8479642620
• MDR Report Key: 4101581
• MDR Text Key: 4719473
• Report Number: 3009974348-2014-00015
• Device Sequence Number: 1
• Product Code: HGY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 08/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 17152
• Device Lot Number: 4E10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/05/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other