MAUDE Adverse Event Report: MEDLINE RENEWAL UNKNOWN; SUTURE PASSER

Model Number UNKNOWN

Device Problem Material Integrity Problem (2978)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Medline renewal received a report that tips of multiple reprocessed suture needles detached during the course of use.No additional information surrounding the reported incident(s) is available at this time, and medline renewal did not receive any communication from the facility at the time of the reported incidents.Therefore medline renewal is unable to confirm if the failed devices were reprocessed, and/or if they were reprocessed by medline renewal.The failed device(s) model numbers, lot numbers, and shipping information were not received, therefore no additional manufacturing review or process record reviews could be conducted.However, in an abundance of caution medline renewal is filing this medwatch form.(b)(4) device not returned to manufacturer.

Event Description

Medline renewal received a report that tips of multiple reprocessed suture needles detached during the course of use.No additional information surrounding the reported incident(s) is available at this time, and medline renewal did not receive any communication from the facility at the time of the reported incidents.Therefore medline renewal is unable to confirm if the failed devices were reprocessed, and/or if they were reprocessed by medline renewal.However, in an abundance of caution medline renewal is filing this medwatch form.

• Brand Name: UNKNOWN
• Type of Device: SUTURE PASSER
• Manufacturer (Section D): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• Manufacturer (Section G): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• Manufacturer Contact: brandi panteleon ; 2747 sw 6th st.; redmond, OR 97756 ; 5415164180
• MDR Report Key: 6088128
• MDR Text Key: 59458774
• Report Number: 3032391-2016-00010
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention