MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; FORCEP,HEMO,KELLY,STR,5.5",14CM

Catalog Number MDS1224014

Device Problems Break (1069); Difficult to Remove (1528)

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

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported, "the hemostat broke off during a procedure and was not easy to retrieve." email received by (b)(6), (b)(6), with additional information related to this incident.Reporter states, incident occurred (b)(6) 2021 hemostat broke off during a pacemaker procedure to the upper subclavian pocket area.Reporter did not identify how the physician retrieved the broken piece of the hemostat.Reporter denies serious injury occurred.Patient was under general anesthesia, it was not reporter if patient required additional anesthesia because of this incident.Reporter states, patient is "fine." no sample available for return and evaluation.Due to the reported incident, medical intervention and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported, "the hemostat broke off during a procedure and was not easy to retrieve.".

Event Description

It was reported, "the hemostat broke off during a procedure and was not easy to retrieve.".

Manufacturer Narrative

Changed/additional information added.D9 device available for evaluation -n/a.G6 type of report - follow-up.H2 if follow-up what type? additional information.H3 device evaluated by manufacturer - n/a.H6 type of investigation-4109, 4110, 4114.H5 investigation conclusion - zcd00006/unconfirmed defect, 0003/sample required to determine cause.H10 investigation report reads as follows: investigation summary: "(b)(6) 2021 10:42:10 cst (rpipes).Medline quality did not receive a physical nor visual sample of mds1224014 for evaluation.It was reported that the hemostat broke off during a procedure this afternoon.This concern was logged as qa 200428934.Per the clinical investigation, it was reported that this incident occurred on 1/2/2021.The hemostat broke off during a pacemaker procedure to the upper subclavian pocket area.It was not reported how the physician retrieved the broken piece.Since a physical nor visual sample was received for investigation the investigation included review of the sku and recent complaint trends/scar activity for the past year.If a sample becomes available at a later date, the complaint will be re-opened and the sample evaluated.A retrospective review of the past year for this product indicated that there have been no prior complaints in regards to this issue.The division will continue to monitor this issue for trending.A one each replacement of mds1224014 was issued to the account per no cost sales order 525047427.Ok to close.(b)(6) 2021 08:42:21 cst (rpipes).At this time due to the complaint being logged for instrument breakage into the patient, per the clinical investigation this concern will be confirmed.Although a sample was not received, our manufacturing site will be notified of the issue.".

• Type of Device: FORCEP,HEMO,KELLY,STR,5.5",14CM
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11358804
• MDR Text Key: 234247461
• Report Number: 1417592-2021-00020
• Device Sequence Number: 1
• Product Code: HRQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MDS1224014
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention