MAUDE Adverse Event Report: UNOMEDICAL LTD. UMBILICAL CORD CLAMP; OPERATION ACCESSORIES

Model Number 460-00

Device Problem Free or Unrestricted Flow (2945)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/17/2011

Event Type  Injury  

Event Description

Product does not grip tightly enough and does not stop the blood flow.This has caused a baby to need blood transfusion in intensive care.

Manufacturer Narrative

Based on the available information, this event is deemed a serious injury and the device was used on a pt.No additional pt/event details have been provided to date.Should additional information become available a follow-up report will be submitted.A return sample for evaluation is not expected.Convatec will continue to observe for trends regarding these complaint types.This mdr is being reported as a result of a retrospective review of complaint records conducted by convatec for complaints received from may 1, 2011- september 30, 2013.Note: the actual date of event is unknown, so the date used was the date convatec became aware.

• Brand Name: UMBILICAL CORD CLAMP
• Type of Device: OPERATION ACCESSORIES
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street 50; fanipol; dzerzhinsk district minsk region 2227 50; BO 222750
• Manufacturer Contact: matthew walenciak ; 200 headquarters park drive; skillman, NJ 08558 ; 9083779293
• MDR Report Key: 3812672
• MDR Text Key: 4528552
• Report Number: 3007966929-2014-00015
• Device Sequence Number: 1
• Product Code: HFW
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/17/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 460-00
• Device Catalogue Number: 460-00
• Device Lot Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention