MAUDE Adverse Event Report: CAREFUSION, INC VITAL NEIVERT NDL HLDR 1OFFSET RING 5IM; HOLDER, NEEDLE, GASTROENTEROLOGIC

Model Number	RH2551
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 10aug2015 customer advocacy sent the customer an email acknowledging receipt of the complaint, providing the complaint number, and inquiring if additional information was available.Confirmation was also requested from the customer that there was no patient impact associated with the reported issue.Customer advocacy contact information was provided.Pictures of the sample were sent to the supplier and an evaluation determined improper use by the customer was the cause of the instrument tip breaking off.
Event or Problem Description
Distributor, (b)(4), called to verbally state that the end user was using the item during a procedure and it broke off.The broken part was retrieved.It was verified with end user that there was no patient harm.On 27aug2015 additional information was provided.This incident occurred while closing a surgical site.A piece of the instrument fell into the surgical site and was retrieved by the surgeon with another instrument.An x-ray was performed on the patient to confirm the location of the broken off piece of the instrument.The procedure was completed as planned with the expected outcome without complications.

• Brand Name: VITAL NEIVERT NDL HLDR 1OFFSET RING 5IM
• Common Device Name: HOLDER, NEEDLE, GASTROENTEROLOGIC
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 10832974
• Report Number: 1423507-2020-00054
• Device Sequence Number: 2914097
• Product Code: FHQ
• UDI-Device Identifier: 10885403114168
• UDI-Public: (01)10885403114168
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2020

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 Model Number: RH2551
• Device Catalogue Number: RH2551
• Device Lot Number: XHEV11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2015
• Initial Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other