MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; OH INSTRUMENTAL SPINE PACK A&B

Catalog Number DYNJ64013

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/01/2021

Event Type  Injury  

Event Description

It was reported that the wound drain was removed postoperatively by the patients spouse and broke in half during removal resulting in the patient requiring additional surgery to retrieve the retained portion of the drain.

Manufacturer Narrative

It was reported that a male patient, with a wound drain inserted in the thoracic area of the back, required additional surgery to remove a portion of the wound drain due to the wound drain breaking off inside the patient postoperatively when the spouse was attempting to remove the drain.According to the facility operating room manager the patient's wife was instructed to remove the drain at home on postop day 7.When the spouse went to remove the drain it broke at the clear plastic tubing leaving the white perforated section in the patient.The patient was scheduled to return to surgery to remove the remaining portion of the drain.The patient is reported to be doing well.The sample is not available to be returned to the manufacturer for evaluation.There was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

• Type of Device: OH INSTRUMENTAL SPINE PACK A&B
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 11228722
• MDR Text Key: 241236179
• Report Number: 1423395-2021-00008
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ64013
• Device Lot Number: 20CDC108
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2021
• 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?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 78