MAUDE Adverse Event Report: TRI-STATE DE MEXICO MEDLINE INDUSTRIES, INC.; GOMCO CLAMP 1.3CM

Model Number DYND04131

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/11/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient was noted to have experienced "abnormal bleeding." the reporting facility indicated that some of their gomco clamps were noted to have missing washers, washers that were "embedded and attached, and washers that were "free floating." the patient required the application of avitene to the procedural site to address the reported abnormal bleeding.No further patient impact, medical treatment, or follow-up care was reported.A sample was returned by the reporting facility and sample investigation is ongoing.Due to the reported need for medical treatment, this medwatch is being file.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the patient was noted to have experienced "abnormal bleeding.".

Manufacturer Narrative

Multiple samples were returned to the manufacturer and evaluation of samples was completed on (b)(6) 2021.Inspection of the returned samples found that some gomco clamps were missing washers.During evaluation of the samples, it was noted that clamp components appeared to be mixed from different manufactures.The dynd04131 gomco clamp is a sterile single-use device that is not intended to undergo further processing.It was determined that the gomco clamps are likely being re-processed and re-assembled which is resulting in missing washers and missing clamp components.No lot number for the device involved in the incident has been provided.If additional relevant information becomes available another supplemental medwatch will be filed.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: GOMCO CLAMP 1.3CM
• Manufacturer (Section D): TRI-STATE DE MEXICO; s. de r.l. de c.v.; mexicali, baja california 21397 ; MX 21397
• MDR Report Key: 11528528
• MDR Text Key: 241043161
• Report Number: 3004519921-2021-00001
• Device Sequence Number: 1
• Product Code: HFX
• UDI-Device Identifier: 10888277937604
• UDI-Public: 10888277937604
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: DYND04131
• Device Catalogue Number: DYND04131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 03/19/2021
• Supplement Dates Manufacturer Received: 02/19/2021
• Supplement Dates FDA Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention