MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC RANEY SCALP CLIPS; CLIPS, SCALP

Catalog Number 20-1037

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2014

Event Type  Injury  

Event Description

It was found that the sterile pouch of the device had already been opened.There were no adverse consequences to the patient.

Manufacturer Narrative

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

Manufacturer Narrative

Upon completion of the investigation it was noted that we received disposable scalp clips in a sealed plastic pouch, see attached photograph.However, the sterile outer pouch was not returned.Without the sterile outer ouch it is not possible to verify the complaint of "sterile pouch of the device had already been opened".It is not possible to determine if the pouch was open in the clinical setting or if it was sent to the customer open.During manufacturing/packaging processes the packaging/product condition is examined prior to releasing the product in inventory.Therefore, it is unlikely that the package would have been released to inventory and shipped to the customer in the open condition.No root cause could be determined.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

• Brand Name: RANEY SCALP CLIPS
• Type of Device: CLIPS, SCALP
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 4358147
• MDR Text Key: 5179384
• Report Number: 1226348-2014-12158
• Device Sequence Number: 1
• Product Code: HBO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 20-1037
• Device Lot Number: HF603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/08/2015
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention