MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; BREAST AUGMENTATION PACK

Catalog Number DYNJ67266

Device Problem Insufficient Information (3190)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 02/26/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported, "the cautery tip caused patient harm." emailed received by aaron wood, operating room supervisor, texas health harris methodist hospital, with additional information in regards to this complaint.Reporter states on (b)(6) 2021 during a bilateral breast augmentation procedure while using the extended tip cautery on deeper tissue, the physician noted there was a burn to the superficial skin on the lower side of the chest incision.Reporter states, "they noted the burn mark on the skin and looked at the shaft of the cautery, noticed there was a break in the insulation and immediately removed the faulty cautery tip from the field." reporter states no serious injury.However reports, "the burnt tissue would be sharply debrided, and primary closure would still be performed." patient was under general anesthesia and it is unknown if patient required additional sedation due to this incident.The sample is available and has been requested for return and evaluation.Reporter states, "no further issues to the best of their knowledge" in regards to this patient.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 cautery tip caused patient harm.".

Manufacturer Narrative

Changed/additional information added.D9 device available for evaluation -yes.H2 if follow-up what type? device evaluation.H3 device evaluated by manufacturer - yes, evaluation summary attached.H6 type of investigation-10, 4110, 4113.H5 investigation conclusion -25 cause/ defect confirmed: supplier mfg./error (non-medline branded).H10 investigation report reads as follows, 3/22/2021.Investigation summary: investigation summary: 03/22/2021 09:29:12."sample evaluation: a sample was received for our investigation.A sample was received of an extension bovie tip for our investigation; the rest of the pack was not received at this time.Upon physical inspection of the received sample it was seen that there was an indent in the insulation that went to the metal core and appeared to be burnt.Upon further inspection it was seen that the very tip of the bovie was charred, there appeared to be no other physical damage on the received device.Reviewed pack's production records: there were no non-conformances related to the reported issue.Reviewed pack build: the cautery tip is placed into emesis basin with other components.Trending: trending was reviewed and there have been 0 additional reported complaint(s) for this issue in the past 6 months.Component trending was reviewed and there have been one additional reported complaint(s) for this issue for component 30371 the last 6 months.Investigation summary: the account reported finding faulty insulation on bovie tip.The reported issue occurred in item dynj67266 (lot 20xbe470).Based on the information provided this is likely a vendor product issue.Actions taken and recommendations: this complaint has been provided to the vendor for further evaluation.Our supplier quality team will also monitor this issue for trending purposes.".

Event Description

It was reported, "the cautery tip caused patient harm.".

• Type of Device: BREAST AUGMENTATION PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11457778
• MDR Text Key: 246072165
• Report Number: 1423395-2021-00013
• Device Sequence Number: 1
• Product Code: FTN
• UDI-Device Identifier: 10193489394269
• UDI-Public: 10193489394269
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ67266
• Device Lot Number: 20XBE470
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 03/10/2021
• Supplement Dates Manufacturer Received: 03/04/2021
• Supplement Dates FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR
• Patient Weight: 53