MAUDE Adverse Event Report: CAREFUSION, INC OCHSNER ARTERY FORCEPS STR 6-1/4 1X2 TTH; FORCEPS, GENERAL & PLASTIC SURGERY

Catalog Number SU2800

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/28/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4) - medwatch # (b)(4).07aug2023 writer sent the customer an email acknowledging receipt of the complaint and requested follow up information including as to if there was any patient impact related to this event.Writer provided contact information.Device not yet evaluated, if the device is evaluated a follow up will be sent.

Event Description

Patient was born via cesarian section (c/s).Upon arrival to the infant warmer, it was noted the kocher clamp had come undone resulting in significant blood loss.Apgar score was 1 at 1 min and 5 at 5 min.Baby was admitted to special care nursery for respiratory distress, status post resuscitation, and blood loss from umbilical cord.1.5 hours later, nursing noted desaturations and low blood pressure (bp) requiring transition back to continuous positive airway pressure (cpap) and a normal saline (ns) bolus.Pediatrician contacted neonatology with a decision to transfer for higher level of care.In the neonatal intensive care unit (nicu) baby received blood products.Unknown at this time if this was failure of the user to properly clamp or if the clamp itself did not function as intended.What was the original intended procedure? clamp the newborn umbilical cord.No further information is not available.

Manufacturer Narrative

Pr # (b)(4) follow up: since the product sample and photos are not available, an evaluation could not be performed.The product cannot be investigated properly so the root cause is undetermined.The dhr was reviewed, and no irregularities were found.There have been no issues identified with the material or manufacturing process.The product would have been manufactured and tested according to the specifications h3 other text : no device received.See h10.

Event Description

Patient was born via cesarian section (c/s).Upon arrival to the infant warmer, it was noted the kocher clamp had come undone resulting in significant blood loss.Apgar score was 1 at 1 min and 5 at 5 min.Baby was admitted to special care nursery for respiratory distress, status post resuscitation, and blood loss from umbilical cord.1.5 hours later, nursing noted desaturations and low blood pressure (bp) requiring transition back to continuous positive airway pressure (cpap) and a normal saline (ns) bolus.Pediatrician contacted neonatology with a decision to transfer for higher level of care.In the neonatal intensive care unit (nicu) baby received blood products.Unknown at this time if this was failure of the user to properly clamp or if the clamp itself did not function as intended.What was the original intended procedure? clamp the newborn umbilical cord.No further information is not available.

• Brand Name: OCHSNER ARTERY FORCEPS STR 6-1/4 1X2 TTH
• Type of Device: FORCEPS, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 17567650
• MDR Text Key: 321377830
• Report Number: 1423507-2023-00096
• Device Sequence Number: 1
• Product Code: GEN
• UDI-Device Identifier: 10885403064562
• UDI-Public: (01)10885403064562
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/17/2023,10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SU2800
• Device Lot Number: D23XMR
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2023
• Initial Date Manufacturer Received: 08/04/2023
• Initial Date FDA Received: 08/17/2023
• Supplement Dates Manufacturer Received: 08/04/2023
• Supplement Dates FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female