MAUDE Adverse Event Report: ETHICON INC. UMB TAPE WHT 2X18INX1/8IN NON NDL; CLASS I DEVICE - EXEMPT

Catalog Number	U10T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a newborn underwent umbilical cord tying on an unknown date an suture was used.When using the tape on the umbilical cord, it cuts causing bleeding from it.Like the knot is being released easily and it leaves the cord and began to bleed.Despite making 3 knots of the hiladillo to cut the umbilical cord, the patient has abundant bleeding from it.It should be noted that these procedures of ligation and tying of the umbilical cord, in these cases, were performed by the pediatricians and residents of neonatology, in the newborn.Additional information was requested.The case was discharged without known sequelae.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H6 component code: g07002 no device problem found.Additional information was requested, and the following was obtained: question no.1: provide patient demographic information.Case 1: sex f; age 38 weeks; weight 3.88 kg questions no.2: describe any medical/surgical interventions required for this suturing event, including dates and results.The three (3) cases were by cesarean section, the hiladillo tape was used to ligate the umbilical cord.Question no.3: did the operating surgeon observe any suture deficiency or abnormality before, during, after suture placement, or during any reoperation? only when using the yarn tape on the umbilical cord does it cut causing bleeding.Likewise, the knot is easily released.Questions no.4: how was the suture originally tied (multiple knots, square knot, etc.)? it is unknown.Questions no.5: what was the volume of blood loss? it is unknown.Question no.6: how did the bleeding stop? questions no.7: other relevant patient history/concomitant medications? question no.8: what is the doctor's opinion as to the etiology or contributing factors to this event? a stranger.Question no.9: what is the patient's current status? the case was discharged without known sequelae.The reported situations revolve around failure to tie the umbilical cords with subsequent bleeding in the umbilical cord.Field investigations were carried out, which included review of clinical records, both paper and electronic.During the investigations,, no record of findings, anomalies, interventions, or follow-ups related to the reported situation was found.Device history review: a manufacturing record evaluation was performed for the finished device lot number al6753/xyu10t, and no non conformances / manufacturing irregularities were identified.Manufactured date: 22.01.2019.Expired date: 31.12.2023.

• Brand Name: UMB TAPE WHT 2X18INX1/8IN NON NDL
• Common Device Name: CLASS I DEVICE - EXEMPT
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra; km 154; sao paulo 12240 ; BR 12240
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17836115
• Report Number: 2210968-2023-07121
• Device Sequence Number: 18085238
• Product Code: EXM
• UDI-Device Identifier: 10705031051034
• UDI-Public: 10705031051034
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

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 Expiration Date: 12/31/2023
• Device Catalogue Number: U10T
• Device Lot Number: AL6753
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 3 KG