MAUDE Adverse Event Report: MEDLINE RENEWAL; REPROCESSING MISCELLANEOUS

Catalog Number DIV65

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

Medwatch report number (b)(4), filed by (b)(6) hospital.It was reported, "part of renewal reprocessed multi-fire scorpion needle broke off in the patient's shoulder.It was quickly removed.No patient injury." no additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.Due to the reported incident, medical intervention and in an abundance of caution, this medwatch is being filed.No sample is available for return and evaluation therefore, a root cause will be difficult if not impossible to determine.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported, "re-processed multi-fire scorpion needle was used for the procedure.Part of the needle broke off in the patient's shoulder.It was quickly removed.".

• Type of Device: REPROCESSING MISCELLANEOUS
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock avenue; redmond OR 97756
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, IL 60093 ; 2249311514
• MDR Report Key: 11686099
• MDR Text Key: 248643175
• Report Number: 3032391-2021-00005
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: DIV65
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 75