MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; NORTH MINOR PACK-LF

Model Number	DYNJ0166780Q
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported; "laps from the medline surgical packs are falling apart and leaving threads within patients, putting them at risk for surgical infections and repeat surgeries." email received by (b)(6), clinical nurse manager surgery, (b)(6) hospital, whom provided additional information in regards to this incident.Reporter states, this incident occurred on (b)(6) 2021 during a bilateral breast tissue expander/implant exchange.Reporter confirms the lap sponges were not used to wipe sharp instruments or catheters.The threads were noted to be in the surgical site and were removed via irrigation and forceps.Reporter states, there was no serious injury identified.General anesthesia used during the procedure and no additional anesthesia was required.Please see sample evaluation report below.Due to the reported incident, medical intervention and in an abundance of caution, this med watch is being filed.If any further relevant information is identified or obtained, a supplemental med watch will be submitted.On 09/23/2021, 21:16:59 cst ((b)(4)) sample evaluation: "a sample was received for our investigation.We received one small piece of white thread in a biohazard bag as a sample for our investigation.We did not receive an entire piece of a lap sponge, the bundle of laps, or the rest of the pack at this time.We observed that the thread likely came from the reported lap sponge.From this, we are unable to determine how this piece of thread detached from the rest of the sponge.Investigation summary: the account reported finding laps are falling apart during use.The reported issue occurred in item dynj0166780q (lot 21gma942).We could not determine root cause for reported issue from the returned sample.".
Event or Problem Description
It was reported; "laps from the medline surgical packs are falling apart and leaving threads within patients, putting them at risk for surgical infections and repeat surgeries.".

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: NORTH MINOR PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12526694
• Report Number: 1423395-2021-00042
• Device Sequence Number: 19979453
• Product Code: LRO
• UDI-Device Identifier: 10193489866346
• UDI-Public: 10193489866346
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYNJ0166780Q
• Device Catalogue Number: DYNJ0166780Q
• Device Lot Number: 21GMA942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Weight: 82