MAUDE Adverse Event Report: CAREFUSION CIRCUMCISION TRAY DISPOSABLE 10/CS; CLAMP, CIRCUMCISION

Model Number OB-1000

Device Problem Material Integrity Problem (2978)

Patient Problem Injury (2348)

Event Date 07/24/2014

Event Type  Injury  

Event Description

Via email, cardinal health reported that the 5 inch probe with eye contained in the circumcision tray pack had a razor sharp tip that cut a baby twice causing the baby to get stitches on his penis.There was injury reported and clinical data has been requested due to the nature of the issue.Customer provided several lot numbers and does not know what lot this tray came from.  lots: 0000625883, 0000620788, 0000610336, 0000583144, 0000615655. on (b)(6) 2014, via telephone, nurse manager ((b)(6)) provided the following additional information: newborn¿s date of birth: (b)(6) 2014.The clinician performing the circumcision is a very experienced pediatrician who has performed many circumcisions before, specifically with this tray, as this is the only tray that has been used in the facility for years.The issue was that the 5 inch probe that came in the tray which is used to separate the foreskin from the shaft of the penis before the procedure, had an unusually sharp edge, when it is usually a blunt instrument.The probe cut the newborn¿s penis twice.There was no blood loss or any other impact, the newborn just needed stitches.The nurse manager indicated the newborn is fine now and was discharged home.The hospital followed up with newborn¿s parents on (b)(6) 2014 and the newborn is healing well and doing fine.The instrument was disposed of so is not available for evaluation.The nurse manager indicated this is the only incident of its kind in the facility.

Manufacturer Narrative

(b)(4).Upon completion of the investigation, a follow up report will be submitted.

• Brand Name: CIRCUMCISION TRAY DISPOSABLE 10/CS
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION 2200, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 4034000
• MDR Text Key: 4724940
• Report Number: 1625685-2014-00133
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K884290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/25/2014

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: Physician
• Device Model Number: OB-1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2014
• Initial Date FDA Received: 08/25/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 DA