MAUDE Adverse Event Report: CARDINAL HEALTH 200 LLC FORCEP ROCH-PEAN CLAMP, DISPOSABLE MAYO CLAMP; FORCEPS, GENERAL AND PLASTIC SURGERY

Catalog Number	09-1360B
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/31/2019
Type of Reportable Event	Malfunction
Event or Problem Description
¿during repair of vaginal delivery, roch-pean clamp ¿popped off¿.Md states ¿had the clamp been placed on the fetal side of the umbilical cord instead of the maternal side of the umbilical cord the baby could have bled to death¿.Md requesting for radar to be written and fda report on device failure to be made.¿.

• Brand Name: FORCEP ROCH-PEAN CLAMP, DISPOSABLE MAYO CLAMP
• Common Device Name: FORCEPS, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): CARDINAL HEALTH 200 LLC
• MDR Report Key: 8306520
• Report Number: MW5083703
• Device Sequence Number: 11206178
• Product Code: GEN
• UDI-Device Identifier: 10888439207811
• UDI-Public: (01)10888439207811
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/01/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 09-1360B
• Device Lot Number: 113628 (LIKE ITEM, ACT DISPOSE
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 3