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

Catalog Number 09-1360B

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 01/31/2019

Event Type  malfunction  

Event 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
• Type of Device: FORCEPS, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): CARDINAL HEALTH 200 LLC
• MDR Report Key: 8306520
• MDR Text Key: 135722534
• Report Number: MW5083703
• Device Sequence Number: 1
• Product Code: GEN
• UDI-Device Identifier: 10888439207811
• UDI-Public: (01)10888439207811
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 09-1360B
• Device Lot Number: 113628 (LIKE ITEM, ACT DISPOSE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 3