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

Model Number	DYND04131
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/11/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the patient was noted to have experienced "abnormal bleeding.".
Additional 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.
• Common Device Name: 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
• Report Number: 3004519921-2021-00001
• Device Sequence Number: 14393755
• Product Code: HFX
• UDI-Device Identifier: 10888277937604
• UDI-Public: 10888277937604
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 03/29/2021
• 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